A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) with VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients with Plaque Psoriasis

To compare the safety and efficacy of the test (Tapinarof Cream 1%), placebo (vehicle cream) and reference VTAMA® (Tapinarof Cream 1%) treatments to demonstrate clinical equivalence in patients with plaque psoriasis.

Start Date17 Dec 2024

Sponsor / Collaborator

Teva Pharmaceuticals USA, Inc.

[+1]

NCT06661213

/ Not yet recruitingEarly Phase 1IIT

Tapinarof for Cutaneous Lupus Erythematosus

We hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to improvement of cutaneous lupus lesions. To test this hypothesis, we will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. This trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical AHR agonist application. The goals are to 1) identify if topical AHR agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical AHR agonist treatment.

Start Date01 Dec 2024

Sponsor / Collaborator

Northwestern University

ChiCTR2400093238

/ SuspendedPhase 4IIT

Clinical observation of sequential topical Mometasone Furoate Cream versus Tapinarof in the treatment of atopic dermatitis in adults

Start Date01 Dec 2024

Sponsor / Collaborator

Xiangya Hospital Central South University

100 Clinical Results associated with Benvitimod

100 Translational Medicine associated with Benvitimod

100 Patents (Medical) associated with Benvitimod

682

Literatures (Medical) associated with Benvitimod

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials

Article

Author: Rubenstein, David S. ; Gold, Linda Stein ; Piscitelli, Stephen C. ; Ehst, Benjamin D. ; Green, Lawrence J. ; Zirwas, Matthew J. ; Del Rosso, James ; Brown, Philip M. ; Tallman, Anna M.

Background: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes.Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck.Results: 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0-1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3-0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2-0.4 (burning/stinging) and 0.6-0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0-0.3 versus 0-1.0).Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas.Clinicaltrials.gov numbers NCT05014568, NCT05032859.

01 Mar 2025·JOURNAL OF HOSPITAL INFECTION

In-vitro assessment of oral fluid aspiration by various high-speed air-turbine dental handpieces

Article

Author: Liu, Ruolan ; Sun, Manlin ; Yang, Xin ; Wang, Yingkai ; Zhu, Jiakang ; Zhao, Yuwei ; Yu, Haiyang ; Sun, Jikui

BACKGROUND:

The control of aspiration contamination of dental handpiece (DHP) is crucial for mitigating cross-infection risks associated with dental chair units (DCU) and DHP. However, the anti-aspiration capabilities of DHPs are predominantly asserted by manufacturers, with an absence of standardized methodologies to assess these claims.

AIM:

To evaluate the anti-aspiration performance and the mechanism of DHPs to improve cross-infection prevention strategies.

METHODS:

Five different manufacturers of DHPs included SMART torque S609C (Group SMART), TWINPOWER TURBINE 4H PAR-4HUEX (Group TWIN), T3 mini-Midwest (Group T3), TU (Group TU) and disposable DHP (Group Hpdove) were selected. The aspiration pressure index was compared by the changes in liquid levels. The colony counts of Streptococcus mutans in connecting tubes of the DCU were compared under model F (full DHP head immersion) and model H (half dental bur immersion).

FINDINGS:

Group TWIN exhibited zero aspiration pressure index, indicating zero aspiration pressure. Under model H, the bacterial counts were observed in the exhaust tubes of four groups (P<0.001), excluding group TWIN. The bacterial counts in exhaust tubes under model H were significantly lower than those under model F (P≤0.003).

CONCLUSION:

The TWIN DHP demonstrating the best anti-aspiration capability with lowest aspiration pressure index and the least bacterial counts in the exhaust tubes under model H. Half dental bur immersion reduces the risk of cross infection than full DHP head immersion. The anti-aspiration analysis model developed in this study could serve as the basis for an ISO to benchmark DHP manufacturer claims and help control the cross-infection risks associated with DCU.

01 Feb 2025·JOURNAL OF DERMATOLOGY

A phase 2, randomized, double‐blind, vehicle‐controlled trial of tapinarof cream in Japanese pediatric patients with atopic dermatitis

Article

Author: Murata, Ryusei ; Igarashi, Atsuyuki ; Fukasawa, Shuichi ; Tsuji, Gaku ; Yamane, Satoshi

Abstract:

Tapinarof is a nonsteroidal, topical, aryl hydrocarbon receptor agonist approved for the treatment of atopic dermatitis (AD) in Japanese patients aged ≥12 years. We evaluated the efficacy and safety of tapinarof in Japanese pediatric patients aged 2 to 11 years with AD in a phase 2, multicenter, randomized, double‐blind, vehicle‐controlled trial. Eligible patients (N = 121) were randomized 1:1:1 to receive tapinarof cream 0.5%, tapinarof cream 1%, or vehicle cream once daily for 8 weeks. At week 8, the least‐squares mean percent change from baseline in Eczema Area and Severity Index (EASI) score (the primary endpoint) was −81.29% in the tapinarof 0.5% group, −77.62% in the tapinarof 1% group, and − 18.56% in the vehicle group. Reductions in EASI score at week 8 were significantly greater in the tapinarof groups than in the vehicle group (p < 0.0001 for both comparisons). The proportion of patients with ≥75% improvement from baseline in EASI score at week 8 was 77.5% in the tapinarof 0.5% group, 70.7% in the tapinarof 1% group, and 15.0% in the vehicle group. The proportion of patients who achieved an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear) with ≥2‐grade improvement from baseline at week 8 was 32.5% in the tapinarof 0.5% group, 43.9% in the tapinarof 1% group, and 17.5% in the vehicle group. No treatment‐related serious adverse events (AEs) were reported; all of the AEs were mild or moderate. Common AEs in tapinarof‐treated patients included gastroenteritis, application site irritation, and nasopharyngitis. The incidence of trial discontinuations due to AEs was low in tapinarof‐treated patients (one patient for each strength). In summary, both strengths of tapinarof cream demonstrated greater efficacy than vehicle cream and were well tolerated in Japanese pediatric patients with AD.

111

News (Medical) associated with Benvitimod

10 Feb 2025

·investor.roivant.com

Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2024, and provided a business update. Brepocitinib to be developed in third indication, cutaneous sarcoidosis (CS), an orphan indication with high unmet need; Phase 2 study initiation expected in second quarter of calendar year with topline data in second half of calendar year 2026 IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiated Batoclimab topline results from pivotal trial in myasthenia gravis (MG) and initial results from period 1 of trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025 Progress in ongoing LNP litigation, with the summary judgment phase in the Moderna case taking place across the second and third quarters of calendar year 2025 and a jury trial scheduled for September 2025 Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement “Roivant has broadened our clinical pipeline with the newly announced trial of brepocitinib in cutaneous sarcoidosis. As with dermatomyositis and non-infectious uveitis, brepocitinib has the potential to be a first-in-class agent for CS and expands the treatment options for patients suffering from an indication with high unmet need,” said Matt Gline, CEO of Roivant. “We also look forward to announcing multiple significant study outcomes this year including for batoclimab in MG, CIDP and TED, and for brepocitinib in dermatomyositis. 2025 is a year of harvest for Roivant.” Recent Developments Immunovant:In January 2025, Immunovant announced a $450 million private placement with participation from a U.S.-based healthcare focused investor, a large mutual fund complex, and Roivant, bringing Roivant’s basic ownership up to approximately 57%.Endocrinology ProgramImmunovant recently initiated the first potentially registrational trial of IMVT-1402 in adult participants with GD who are hyperthyroid despite antithyroid drug (ATD) treatment. This study builds on the batoclimab proof-of-concept data presented in 2024, which suggest the potential for deep IgG reduction in the treatment of GD for patients who are not well controlled on ATDs.Rheumatology ProgramImmunovant recently initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive difficult-to-treat rheumatoid arthritis. The trial includes IMVT-1402’s higher dose (600 mg) as recent in-class data suggest that deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Priovant: In February 2025, Priovant announced a Phase 2 study of the safety and efficacy of brepocitinib in adults with cutaneous sarcoidosis. Cutaneous sarcoidosis marks the third indication for brepocitinib and continues the strategy to develop the drug in orphan indications with high unmet need. There are 30,000 to 50,000 patients in the US affected by cutaneous sarcoidosis with no approved therapies. The trial is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Genevant: The Pfizer / BioNTech Markman hearing was held in December 2024. Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement.In December 2024, Roivant announced Kinevant’s Phase 2 study of namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. Kinevant is discontinuing further development of namilumab for the treatment of sarcoidosis. Major Upcoming Milestones Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. Neurology ProgramImmunovant intends to report topline results from the pivotal trial of batoclimab in MG by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and inform the design of a potentially registrational program for IMVT-1402 in MG, which Immunovant expects to initiate following the disclosure of the batoclimab data in MG.Results from period one of the trial evaluating batoclimab in CIDP continue to be expected by March 31, 2025. Those results, as well as observations drawn from public disclosures of other studies in CIDP, are expected to inform a potentially registrational program for IMVT-1402 in CIDP, which Immunovant expects to initiate following the disclosure of the batoclimab CIDP data.Endocrinology ProgramImmunovant plans to announce additional data from the batoclimab proof-of-concept study in GD including 6-month, treatment-free remission data designed to further articulate potential for IMVT-1402 in GD. These data are expected in the summer of 2025.Topline results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025, along with a decision whether to pursue marketing authorization for batoclimab in TED. Data from this trial may also inform the IMVT-1402 program in GD. Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027.Priovant’s Phase 2 trial of brepocitinib in cutaneous sarcoidosis is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026. Genevant litigation against Moderna continues to progress with summary judgment phase scheduled for second and third quarter of calendar year 2025; Moderna jury trial scheduled for September 2025. Third Quarter Ended December 31, 2024 Financial Summary Cash Position and Marketable Securities As of December 31, 2024, the Company had consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $5.2 billion. Research and Development Expenses Research and development (R&D) expenses increased by $33.4 million to $141.6 million for the three months ended December 31, 2024, compared to $108.1 million for the three months ended December 31, 2023. This increase was primarily driven by increases in program-specific costs of $26.2 million, personnel-related expenses of $3.9 million, and share-based compensation of $2.8 million. Within program-specific costs, the increase of $26.2 million was primarily driven by an increase in expense of $29.1 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $5.7 million related to RVT-3101, which was sold to Roche in December 2023. Non-GAAP R&D expenses were $131.2 million for the three months ended December 31, 2024, compared to $100.2 million for the three months ended December 31, 2023. General and Administrative Expenses General and administrative (G&A) expenses increased by $13.4 million to $141.5 million for the three months ended December 31, 2024, compared to $128.2 million for the three months ended December 31, 2023. This increase largely resulted from an increase in share-based compensation expense of $25.0 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. This increase was partially offset by a decrease in personnel-related expenses of $15.9 million, primarily due to higher expense in the three months ended December 31, 2023 related to a special one-time cash retention bonus award granted to employees, following approval in December 2023. Non-GAAP G&A expenses were $71.1 million for the three months ended December 31, 2024, compared to $82.6 million for the three months ended December 31, 2023. Income (loss) from discontinued operations, net of tax Income from discontinued operations, net of tax was $327.0 million for the three months ended December 31, 2024 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $58.5 million for the three months ended December 31, 2023, representing the financial results of Dermavant during this period. (Loss) income from continuing operations, net of tax Loss from continuing operations, net of tax was $208.9 million for the three months ended December 31, 2024, compared to income from continuing operations, net of tax of approximately $5.1 billion for the three months ended December 31, 2023. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.22 for the three months ended December 31, 2024. On a basic and diluted per common share basis, income from continuing operations, net of tax was $6.44 and $6.10, respectively, for the three months ended December 31, 2023. Non-GAAP loss from continuing operations, net of tax was $143.7 million for the three months ended December 31, 2024, compared to $138.0 million for the three months ended December 31, 2023. Notes to non-GAAP financial measures: (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. (3) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023 and a gain on the achievement of a one-time milestone in June 2024. (4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (6) Represents the one-time gain on deconsolidation of subsidiaries. (7) Represents the estimated tax effect of the adjustments. Investor Conference Call InformationRoivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 10, 2025, to report its financial results for the third quarter ended December 31, 2024, and provide a corporate update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About RoivantRoivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com Print Page Email Alerts RSS Feeds IR Contacts

Phase 2Phase 3Financial StatementPhase 1Clinical Result

02 Jan 2025

·medcitynews.com

FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions - MedCity News

For many people, the end of the year is a mad rush to wrap things up before the holidays, and so it was for the FDA. Notable regulatory decisions include the first drug approval for a prevalent chronic condition and a novel regenerative medicine approach to help trauma patients. In one case, a new drug approval comes as its developer takes on a new identity in the new year. Here’s a look back at some highlights from a busy regulatory month: presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical Notable Firsts —The prevalent sleeping disorder obstructive sleep apnea has historically been managed with a medical device that helps breathing. Eli Lilly’s Zepbound is now the first FDA-approved drug treatment for the chronic condition. Obesity is a risk factor for sleep apnea and clinical trial results showed that weight reductions from treatment with Zepbound were accompanied by breathing improvement. Approval in obstructive sleep apnea adds another potential blockbuster indication for a metabolic medication that has fast become one of Lilly’s top-selling products. —Patients who have the rare inherited metabolic disorder familial chylomicronemia syndrome lack the ability to break down triglycerides, a type of fat from food. The only way to avoid potentially fatal complications to the pancreas is by maintaining an extremely restrictive diet. Approval of Ionis Pharmaceuticals’ olezarsen gives patients a therapeutic option. The once-monthly injected genetic medicine, which is designed to block the body’s production of a liver protein that regulates triglyceride metabolism, will be marketed under the brand name Tryngolza. Ionis previously brought drugs through late-stage development and commercialization under partnerships with larger companies. Tryngolza will be the first product Ionis commercializes on its own. —When trauma to an arm or leg requires replacement of a blood vessel, the standard treatment is grafting a vein from the patient or implanting a synthetic vein. Now there’s a new regenerative medicine option. Humacyte won FDA approval for Symvess, a bioengineered blood vessel for restoring blood flow to avoid the loss of a limb when grafting a vein from the patient is not feasible. Here’s more about the biotech’s regenerative technology. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech —Mesoblast’s regulatory approval was a long time coming. In 2020 and 2023, the FDA turned down the Australian company’s application for remestemcel, an allogeneic cell therapy for graft versus host disease, an immune response that develops when donor T cells attack the recipient’s cells following a transplant procedure. Remestemcel, brand name Ryoncil, is a made from mesenchymal stromal cells sourced from the bone marrow of healthy donors. The product’s approval covers acute graft versus host disease that is refractory to treatment with steroids in patients age 2 months and older. It’s the first affirmative regulatory decision for a cell therapy made from mesenchymal stromal cells. Approvals in Immunology —Vtama, an Organon drug acquired from Roivant Sciences earlier this year, received FDA approval as a treatment for atopic dermatitis in adults and children age 2 and older. The drug is topical cream that was initially approved in 2022 as a treatment for plaque psoriasis. Approval in atopic dermatitis brings the product to a much larger dermatologic indication, albeit one served my many branded and generic medications. —In other atopic dermatitis news, Galderma landed FDA approval for nemolizumab, brand name Nemluvio. The drug is an antibody designed to block IL-31, a signaling protein associated with the itch and inflammation of the chronic skin disorder. FDA approval of Nemluvio covers use of the drug in patients age 12 and older who have moderate-to-severe atopic dermatitis. It’s the second approval in the past year for Nemluvio, which was first approved over the summer as a treatment for prurigo nodularis. Rare Disease Regulatory Decisions —Neurocrine Biosciences received approval for Crenessity, a treatment for the rare inherited hormone disorder congenital adrenal hyperplasia. The small molecule helps bring the hormone imbalance back to more normal levels. The FDA approved a pill formulation for adults and an oral solution for pediatric patients. Analysts project Crenessity could achieve blockbuster sales, pending regulatory approvals in other countries. —Novo Nordisk is best known for metabolic medicines, but its rare disease portfolio is getting a boost with FDA approval of Alhemo, a drug that reduces bleeding episodes in patients with either hemophilia A or B. Alhemo, known in development as concizumab, is an antibody designed to bind to TFPI, preventing that protein from blocking factor Xa, a different protein that plays a role in blood clotting. That’s the same mechanism of action as Pfizer’s Hympavzi, which won its FDA approval in October. Both drugs are subcutaneous injections that provide alternatives to intravenously infused hemophilia therapies. But Pfizer’s once-weekly Hmypavzi has a dosing edge over Alhemo, which must be injected once daily. —Vertex Pharmaceuticals is adding a new cystic fibrosis (CF) drug to its portfolio with FDA approval of Alyftrek, which combines three compounds in a single therapy. Like Vertex’s other CF therapies, Alyftrek is a modulator of the CFTR a protein that regulates the movement of chloride ions into and out of cells. Alyftrek’s approval is based on clinical data comparing the once-daily therapy to Trikafta, a Vertex triple combination drug initially approved in 2019 as a twice-daily CF treatment. Results showed Alyftrek was non-inferior to Trikafta on a key measure of lung function and was superior in reducing sweat chloride levels, which is a surrogate indicator of the function of CFTR proteins. Besides the dosing advantage, Alyftrek addresses 31 additional mutations that are not addressable by other CFTR modulators. The Dec. 20 approval of Alyftrek came nearly two weeks ahead of the Jan. 2 target date for a regulatory decision. Developments in Cancer Drugs —The FDA awarded accelerated approval to Merus Therapeutics drug zenacutuzumab as a treatment for advanced cases of two types of cancer: non-small cell lung cancer and pancreatic adenocarcinoma. It’s the first approval for a drug that addresses a genetic signature called an NRG1 gene fusion. Netherlands-based Merus will market the bispecific antibody under the brand name Bizengri. In a deal struck days prior to the approval announcement, Partner Therapeutics licensed U.S. commercialization rights to Bizengri. —The blockbuster AstraZeneca drug Imfinzi expanded its FDA-approved uses to include limited-stage small cell lung cancer that has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The checkpoint inhibitor was first approved in 2017 for bladder cancer and added extensive-stage lung cancer as a new indication in 2020. The drug’s latest approval is based on Phase 3 results showing a 27% reduction in the risk of death compared to a placebo. AstraZeneca said the FDA decision makes Imfinzi the first immunotherapy approved for limited-stage small cell lung cancer. —Xcovery Holdings drug ensartinib, brand name Ensacove, was approved to treat adults with advanced cases of non-small cell lung cancer that is positive for ALK mutations. Patients prescribed the once-daily pill must not have previously received an ALK inhibitor. —Pfizer cancer drug Braftovi landed accelerated approval as a first-line treatment for metastatic colorectal cancer driven by the BRAF V600E mutation. The approval covers use of the drug in combination with Eli Lilly’s Erbitux and the chemotherapy regimen referred to as FOLFOX, both standard colorectal cancer therapies. Braftovi, a small molecule inhibitor of BRAF V600E, was initially approved in 2018 for advanced cases of melanoma. The drug came from Pfizer’s 2019 acquisition of Array Biopharma. —Tevimbra, a cancer immunotherapy developed by BeiGene, received FDA approval as a first-line treatment for gastric and gastroesophageal junction cancers when used in combination with chemotherapy. It’s the second FDA approval for the checkpoint inhibitor, which was approved last March for treating advanced or metastatic esophageal squamous cell carcinoma after prior treatment with chemotherapy. The new year means a new identity for BeiGene. The cancer drug developer is changing its name to BeOne Medicines. Starting Jan. 2, the company’s stock symbol on the Nasdaq will be “ONC.” Rejections, Warnings & More Bad News in Biotech —Astellas Pharma’s bid to bring patients less-frequent eye injections of its drug Izervay was rejected by the FDA. Izervay, approved for treating geographic atrophy in 2023, is administered monthly to slow progression of the vision-loss disorder. Astellas sought approval for every-other-month dosing based on two-year Phase 3 data. According to Astellas, no safety benefit/risk issues were cited but the FDA took issue with a statistical matter related to labelling language proposed by the company. The rejection will limit Izervay’s ability to compete against Apellis Pharmaceuticals’ geographic atrophy drug Syfovre, which is approved for both monthly and every-other-month dosing. —In other Astellas news, the label for menopause drug Veozah now sports a black box warning for the risk of serious liver injury. The warning follows a FDA safety communication issued in September after a postmarketing report of a patient who developed signs and symptoms of liver injury after taking the once-daily pill for about 40 days. Veozah won FDA approval in 2023 as the first in a new class of therapies for menopause. —Applied Therapeutics received a double dose of bad regulatory news. First the FDA rejected the biotech’s application for govorestat, a drug developed as a treatment for the rare metabolic disease galactosemia. According to Applied, the agency cited “deficiencies in the clinical application.” Days after the FDA complete response letter, the FDA sent Applied a warning letter. The trial and the drug are redacted in the public version of the letter, but in a regulatory filing, Applied acknowledged the FDA’s concerns are about the govorestat galactosemia trial. Applied said the warning letter identified issues with electronic data capture and a dosing error in the dose-escalation portion of the study — both of which the company believed it had already addressed with the agency. Applied said it would respond to the FDA warning letter. —Bad news keeps stacking up for Intercept Pharmaceuticals and its drug, Ocaliva, a treatment for the rare liver disease primary biliary cholangitis (PBC). On Dec. 12, the FDA issued a safety alert, warning of the risk of serious liver injury in patients without advanced liver cirrhosis. The alert came one month after the FDA turned down Intercept’s application seeking full approval for Ocaliva, which won its accelerated approval in PBC in 2016. The FDA’s rejection letter for the drug cited safety concerns. When Ocaliva first reached the market, it was the only FDA-approved second-line treatment for PBC. In the past year, drugs from Ipsen and Gilead Sciences have each won accelerated approvals as new second-line therapies for the rare disease. Two weeks after the FDA turned down full approval of Ocaliva, the European Commission revoked the conditional marketing authorization for the drug. Advanz Pharma holds rights to Ocaliva in Europe. The company said the commission decision is subject to an ongoing annulment procedure in the EU’s General Court and a ruling is expected in 2025. —The FDA turned down Zealand Pharma’s glepaglutide as a treatment for short bowel syndrome, a rare disorder that develops when the small intestine is damaged or shortened, making it difficult for the organ to absorb nutrients. The drug is a long-acting GLP-2 analog intended to enhance the intestine’s ability to absorb nutrients, reducing patients’ dependence on intravenous feeding. According to Zealand, the FDA said the application needed more evidence of efficacy and safety. The company said it would discuss the letter with the FDA and proceed with plans to seek European approval in 2025. —Lexicon Pharmaceuticals came up short in its bid to expand approval of its drug, sotagliflozin (brand name Zynquista), to include the treatment of adults with type 1 diabetes and chronic kidney disease. The FDA’s Dec. 20 rejection of the drug followed a negative FDA advisory committee vote in October. The FDA approved sotagliflozin last year as a treatment for heart failure; it’s marketed in this indication under the brand name Inpefa. —Johnson & Johnson received a complete response letter for its injectable version of Rybrevant, a drug that treats cancer driven by EGFR mutations. Intravenously infused Rybrevant was approved in 2021 as a treatment for non-small cell lung cancer. The injectable version is made with technology from Halozyme. J&J said the FDA letter flagged manufacturing issues and did not cite any concerns about the new formulation or its safety and efficacy.

Drug ApprovalImmunotherapyAccelerated ApprovalAcquisitionClinical Result

19 Dec 2024

·www.drugs.com

FDA Expands Approval of Vtama to Include Atopic Dermatitis

THURSDAY, Dec. 19, 2024 -- The U.S. Food and Drug Administration has approved Vtama (tapinarof) 1 percent cream for an additional indication -- the topical treatment of atopic dermatitis in adult and pediatric patients aged 2 years and older. The cream, an aryl hydrocarbon receptor agonist, was previously approved as a topical, nonsteroidal treatment for plaque psoriasis. The approval was based on results from the ADORING 1 and ADORING 2 trials, in which a statistically significant difference in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum two-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD (vIGA-AD) was seen for Vtama compared with vehicle (ADORING 1: 45.4 versus 13.9 percent; ADORING 2: 46.4 versus 18.0 percent). Statistically significant benefits were seen for secondary end points, including an Eczema Area and Severity Index score improvement of at least 75 percent from baseline at week 8 and achievement of a ≥4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline at week 8 in patients aged 12 years and older. Upper respiratory tract infection (12 percent), folliculitis (9 percent), lower respiratory tract infection (5 percent), headache (4 percent), asthma (2 percent), vomiting (2 percent), ear infection (2 percent), pain in extremity (2 percent), and abdominal pain (1 percent) were the most common adverse reactions reported. "With the FDA's approval of Vtama cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected," Kevin Ali, the CEO of Organon, said in a statement. Approval of Vtama was granted to Organon. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug ApprovalClinical Result

100 Deals associated with Benvitimod

External Link

KEGG	Wiki	ATC	Drug Bank
-	Benvitimod	D05	DB06083

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	JP	Japan Tobacco, Inc.	24 Jun 2024
Psoriasis vulgaris	JP	Japan Tobacco, Inc.	24 Jun 2024
Plaque psoriasis	US	Dermavant Sciences, Inc.	23 May 2022
Psoriasis	CN	Guangdong Zhonghao Pharmaceutical Co. Ltd.	29 May 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 3	US	Dermavant Sciences, Inc.	01 Sep 2021
Moderate Atopic Dermatitis	Phase 3	CA	Dermavant Sciences, Inc.	01 Sep 2021
Severe Atopic Dermatitis	Phase 3	US	Dermavant Sciences, Inc.	01 Sep 2021
Severe Atopic Dermatitis	Phase 3	CA	Dermavant Sciences, Inc.	01 Sep 2021
Keratoderma, Palmoplantar	Phase 2	US	Dermavant Sciences, Inc.	30 Oct 2024
Pruritus	Phase 1	JP	GSK Plc	27 Oct 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05142774 (ADORING 3, Biospace) Manual	Phase 3	Dermatitis, Atopic	728	VTAMA cream, 1%	xnesjmiamx(wqtqzsxnrd) = uepretdigt pstxzesedo (ydzahcbjhy ) View more	Positive	25 Oct 2024
NCT05014568 \| NCT05032859 (ADORING 2, Biospace) Manual	Phase 3	Dermatitis, Atopic	813	VTAMA cream (ADORING 1)	vaipotaohh(kuiiqchorh) = mamezzzgzg qufdpgmgqu (zfuzoqvpsw ) View more	Positive	24 Oct 2024
				VTAMA cream (ADORING 2)	vaipotaohh(kuiiqchorh) = wieacbxmpa qufdpgmgqu (zfuzoqvpsw ) View more
ADORING 1 and 2 (ACAAI2024)	Phase 3	Dermatitis, Atopic	813	Tapinarof cream 1%	fugwsqtogw(coeyzytkot) = ugqqrjilmz pkgttflmlb (opyrkbjoku ) View more	Positive	24 Oct 2024
				Vehicle	asljqatioz(bhzvjztvlf) = ciguzcfmpg yjbhwksyzk (swlqnmbrml ) View more
Literature Manual	Not Applicable	Pustulosis of Palms and Soles	47	Benvitimod	acjtaccrsp(cgdiuxovkt) = eluhhjcldh ixebvbgbpy (chflsqspkn ) View more	Positive	22 Oct 2024
NCT05680740 (DMVT-505-4001, CTgov)	Phase 4	Plaque psoriasis	34	VTAMA® (tapinarof) Cream 1%	ubqmymamea(givxydgflp) = vyhoisbfdj ilhzybndcr (kwfwaikgqx, ixjucobliq - yzumnbbohl) View more	-	08 Jul 2024
NCT05014568 (ADORING 1, BusinessWire) Manual	Phase 3	Dermatitis, Atopic	407	VTAMA cream, 1% QD (ASIAN)	hlkaagmdep(isxxhqvskh) = cqswvrpaoe ggrxsqamrt (twmegrnwws ) View more	Positive	08 Mar 2024
				Vehicle QD (ASIAN)	hlkaagmdep(isxxhqvskh) = kgbomwhulc ggrxsqamrt (twmegrnwws ) View more
NCT05032859 (ADORING 2, BusinessWire) Manual	Phase 3	Dermatitis, Atopic	406	VTAMA cream, 1% QD (ASIAN)	tzfjugxjtl(pxtoiittni) = rfqwkyacjf narqrddydb (efqdpxkwyk ) View more	Positive	08 Mar 2024
				Vehicle QD (ASIAN)	tzfjugxjtl(pxtoiittni) = leljotyqsq narqrddydb (efqdpxkwyk ) View more
AAAAI2024	Phase 3	Dermatitis, Atopic	-	Tapinarof cream 1%	hlrxbsqteb(drfhhnnhkl) = dscdxxfgvy ktzrjumdnr (nbluppwwcs )	Positive	23 Feb 2024
				Vehicle	hlrxbsqteb(drfhhnnhkl) = mzcsngztrn ktzrjumdnr (nbluppwwcs )
NCT05142774 (ADORING 3, NEWS) Manual	Phase 3	Dermatitis, Atopic	728	Vtama	ducqjuetfc(xwajoqdpdf) = dwhqarqtbq ezdydqnzdr (aasgtklqbs, 711) View more	Positive	12 Jan 2024
NCT05014568 \| NCT05032859 (DMVT-505-3102 \| ADORING 2, Corporate Publications) Manual	Phase 3	Dermatitis, Atopic	711	VTAMA cream, 1%	bqxdtlvchm(auupnstfhz) = bfiahnfmkt vkejlpnqzu (zbbxalcomz, 711) View more	Positive	11 Jan 2024

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