A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Start Date01 Mar 2025

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

NCT06488170

/ RecruitingNot Applicable

Patient-Reported Wellbeing Using Tildrakizumab in a Live Setting - Light Version

The main purpose of this study to investigate the relationship between clinical symptoms and quality of life (QoL) in participants who receive Tildrakizumab in the frame of clinical routine for the treatment of moderate to severe plaque psoriasis in accordance with the summary of product characteristics (SmPC).

Start Date04 Apr 2024

Sponsor / Collaborator

Almirall SA

NCT06029257

/ RecruitingNot Applicable

Effectiveness and Safety of Tildrakizumab in the Treatment of Genital Psoriasis in Austria, Switzerland, and the Czech Republic

The main aim of this study is to check the safety and effectiveness of tildrakizumab regarding the alleviation of symptoms in the genital area after administration according to the summary of product characteristics (SmPC) and to access overall treatment safety and quality of life assessed on multiple scales.

Start Date14 Nov 2023

Sponsor / Collaborator

Almirall SA

100 Clinical Results associated with Tildrakizumab-ASMN

100 Translational Medicine associated with Tildrakizumab-ASMN

100 Patents (Medical) associated with Tildrakizumab-ASMN

313

Literatures (Medical) associated with Tildrakizumab-ASMN

01 Apr 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: Week 52 results from a phase 3b, randomized, double-blind, placebo-controlled trial

Article

Author: Kothekar, Mudgal ; Nishandar, Tushar ; Yamauchi, Paul S ; Gebauer, Kurt ; Gogineni, Ranga ; Yao, Siu-Long ; Bagel, Jerry ; Kopeloff, Iris ; Sofen, Howard L ; Crane, Michael ; Spelman, Lynda

BACKGROUND:

In the primary analysis of a phase 3b, randomized, double-blind, placebo-controlled study in patients with moderate-to-severe plaque psoriasis affecting the scalp (NCT03897088), tildrakizumab, an anti-interleukin-23 p19 antibody, met the primary efficacy endpoint at week 16.

OBJECTIVE:

To evaluate maintenance of tildrakizumab efficacy and safety for the treatment of scalp psoriasis from the week 52 full analysis.

METHODS:

Patients randomized to tildrakizumab continued receiving tildrakizumab 100 mg every 12 weeks; patients randomized to placebo (analyzed separately) switched to tildrakizumab 100 mg at week 16. Efficacy endpoints included Investigator Global Assessment modified 2011 (scalp) score of 0 or 1 with ≥2-grade improvement and ≥90% improvement in Psoriasis Scalp Severity Index score from baseline. Safety was assessed from adverse events.

RESULTS:

In patients originally randomized to tildrakizumab versus placebo, Investigator Global Assessment modified 2011 (scalp) and ≥90% improvement in Psoriasis Scalp Severity Index score response rates, respectively, improved from 49.4% versus 7.3% and 60.7% versus 4.9% at week 16 to 62.9% versus 56.1% and 65.2% versus 57.3% at week 52; >80% of week 16 responders to tildrakizumab maintained response. No treatment-related serious adverse events occurred.

LIMITATIONS:

Results were obtained under controlled clinical conditions.

CONCLUSION:

Efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are sustained long-term.

01 Mar 2025·Italian Journal of Dermatology and Venereology

Facial psoriasis treated with tildrakizumab

Article

Author: Dragotto, Martina ; Rubegni, Pietro ; Capalbo, Eugenio ; Trovato, Emanuele ; Lamberti, Arianna

01 Mar 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Persistence of advanced systemic pharmacological treatment of moderate‐to‐severe psoriasis among bio‐naïve patients—A retrospective register‐based cohort study in Finland and Sweden

Article

Author: Passey, A. ; Wennerström, C. ; Johnsson, I. ; Hoti, F. ; Mälkönen, T. ; Katus, U. ; Hermanrud, C. ; Westerlund, A. ; Sveide, I. ; Hassan, F. ; Polesie, S. ; Tskhvarashvili, G. ; Saarelainen, L. ; Aher, K. ; Lee, J. ; Nissinen, R.

Abstract:

Background:

Plaque psoriasis (PsO) requires long‐term treatment for symptom control and remission; thus, a long‐term pharmacological intervention is necessary. Treatment persistence reflects long‐term therapeutic effectiveness and tolerance.

Objectives:

This study investigates drug persistence and compares treatment discontinuation rates across biologic agents and apremilast used by PsO patients in Finland and Sweden.

Methods:

This retrospective register‐based cohort study included bio‐naïve patients (≥18 years) with moderate‐to‐severe PsO, who initiated treatment with abatacept, adalimumab, brodalumab, certolizumab pegol, etanercept, golimumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab or apremilast during 2008–2020 in Finland or Sweden. The main analysis evaluated persistence (based on duration of continuous treatment) and compared rates of treatment discontinuation using guselkumab as reference drug, during 2018–2020 in Finland. Treatment discontinuation was assessed by survival analysis of the time to first drug discontinuation, including switching to other study drugs. Due to limited sample size (n < 20), certain biologics (abatacept, brodalumab, certolizumab pegol, etanercept, golimumab, risankizumab and tildrakizumab) were excluded from the persistence analysis.

Results:

In Finland, 709 patients fulfilled the inclusion criteria during 2018–2020 for the main analysis. The highest persistence was observed for guselkumab and ustekinumab with 90 and 85% of treated patients, respectively, continuing treatment for ≥1 year. Comparable results were observed in the expanded cohort analysis (index starting in 2008; 2745 bio‐naïve patients in Finland and 10,970 in Sweden). Furthermore, patients treated with guselkumab in Finland showed lower treatment discontinuation rates compared to other study drugs.

Conclusion:

Guselkumab and ustekinumab demonstrated high persistence as measured by continued treatment for at least 1 year. Furthermore, these treatments demonstrated lower rates of discontinuation compared to other study drugs included in the analysis. Understanding the balance between efficacy and feasibility in treatment decisions is crucial, as feasibility may impact persistency outcomes and potentially increase persistency rates.

News (Medical) associated with Tildrakizumab-ASMN

27 Apr 2025

·pipelinereview.com

TREMFYA® (guselkumab) receives European Commission approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson’s leadership in inflammatory bowel disease

The first a approved fully-human, dual-acting interleukin-23 (IL-23) inhibitor in moderately to severely active ulcerative colitis, 1,2,3,4,5 guselkumab showed statistically higher rates of endoscopic normalisation b at Week 44 compared with placebo. 2,6,7,8,9 Guselkumab is now approved for the treatment of ulcerative colitis in addition to existing indications of plaque psoriasis and psoriatic arthritis in the European Union. 2 BEERSE, Belgium I April 25, 2025 I Johnson & Johnson today announced that the European Commission (EC) has approved a Marketing Authorisation (MA) for TREMFYA ® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 2 UC is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed. 10 Guselkumab is the first a approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64 c , a receptor on cells that produce IL-23. 1,2,3,4,5,11 IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases, d including UC. 11 “Treatment with guselkumab led to significant improvement in the chronic symptoms of ulcerative colitis with the capability of normalising the appearance of the intestinal lining,” said Laurent Peyrin-Biroulet, M.D., Ph.D., Head of the Inflammatory Bowel Disease (IBD) Unit at Nancy University Hospital in France and study investigator. “This approval represents a significant advancement in managing this chronic inflammatory disease.” The EC approval is supported by data from the QUASAR programme, which consists of the Phase 2b induction dose-ranging study and the Phase 3 induction and maintenance studies, evaluating the efficacy and safety of guselkumab in adult patients with moderately to severely active UC who had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment. 2,6,7,8,9 Highlights from QUASAR showed: 2,7 The safety results were consistent with the known safety profile of guselkumab in approved indications for psoriasis (Pso) and psoriatic arthritis (PsA). 2 “There is significant need for new ulcerative colitis therapies that offer meaningful improvements in symptoms and the promise of remission – both overall clinical remission and visible healing of the colon through endoscopic normalisation,” 7,12 said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, J&J Innovative Medicine EMEA. “This approval builds on our sustained efforts to help improve the quality of life of patients, which can be significantly impacted from both a physical and mental health perspective. We look forward to seeing guselkumab continue to raise the bar of efficacy and become the new standard of care in the treatment of UC.” 7 For the treatment of UC, guselkumab is administered as a 200 mg induction dose intravenously at weeks 0, 4, and 8. 2 The recommended maintenance dosage is 100 mg administered by SC injection at week 16, and every 8 weeks (q8w) thereafter. Alternatively, for patients who do not show adequate therapeutic benefit to induction treatment according to clinical judgement, a maintenance dose of 200 mg administered by subcutaneous injection starting at Week 12 and every 4 weeks (q4w), may be considered. 2 This EC approval marks the third indication approved for guselkumab in the European Union (EU), 2 which builds on Johnson & Johnson’s nearly 30-year legacy of immunology innovation. Guselkumab first received approval in the EU in November 2017 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy 1 and received subsequent approval in November 2020 for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy. 13 The EC is also currently reviewing the positive CHMP opinion to expand MA for guselkumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The EC Decision is expected later this year. Editor’s Notes: a) Guselkumab was the first IL-23 inhibitor to be approved in November 2017 for first-line treatment of moderate-to-severe plaque psoriasis. 1,2,3,4,5 b) Also known as endoscopic remission. It is defined as a Mayo Endoscopic Subscore (MES) of 0. 2,14 c) CD64+ cells are the predominant source of IL-23 in IBD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent. 15,16 d) Based on in vitro studies in an inflammatory monocyte model. 15 e) Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. 2,7 ABOUT THE QUASAR PROGRAMME ( EudraCT 2018-004002-25 ) 6 QUASAR is a randomised, double-blind, placebo-controlled, parallel group, multicentre, seamless Phase 2b/3 programme designed to evaluate the efficacy and safety of guselkumab, a selective IL-23 inhibitor, in adult patients with moderately to severely active ulcerative colitis who experienced an inadequate response or who demonstrate intolerance to conventional therapy (e.g., thiopurines or corticosteroids), other biologics and/or JAK inhibitors (i.e., tumor necrosis factor [TNF]-alpha antagonists, vedolizumab, and/or JAK inhibitors (tofacitinib)). 7 QUASAR includes a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomised withdrawal maintenance study, through a total of five years. 7,14 Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points. 6 Full results are available in The Lancet . 7 ABOUT ULCERATIVE COLITIS Ulcerative colitis is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. 10 It is the result of the immune system’s overactive response. 10 Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhoea, abdominal pain, loss of appetite, weight loss, and fatigue. 17 Ulcerative colitis patients also have increased rates of depression. 18 ABOUT GUSELKUMAB Developed by Johnson & Johnson, guselkumab is the first approved fully-human, dual-acting IL-23p19 subunit inhibitor that blocks IL-23 and binds to CD64, a receptor on cells that produce IL-23. 1,2,3,4.5,11 Findings for dual-acting are limited to in vitro studies and the clinical significance of this finding is not known. 15 Guselkumab is approved in the EU for the treatment of moderate to severe plaque psoriasis (Pso) in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying anti-rheumatic drug therapy. 2 It is also approved in the U.S, 19 Canada, 20 Japan 21 and a number of other countries for the treatment of adults with moderate-to-severe Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active PsA. Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab. 1 European Medicines Agency. Tremfya (guselkumab): An overview of Tremfya and why it is authorized in the EU. Available at: https://www.ema.europa.eu/en/documents/overview/tremfya-epar-medicine-overview_en.pdf . Accessed April 2025. 2 J&J Data on file (RF-433976). European Medicines Agency. Updated TREMFYA Summary of Product Characteristics. Accessed April 2025. 3 EU SmPC: European Medicines Agency. Ilumetri Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/ilumetri-epar-product-information_en.pdf . Accessed April 2025. 4 EU SmPC: European Medicines Agency. Skyrizi Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/skyrizi-epar-product-information_en.pdf . Accessed April 2025. 5 Electronic Medicines Compendium. EU SmPC: European Medicines Agency. Omvoh Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/14882/smpc#gref . Accessed April 2025. 6 EU Clinical Trials Register: Clinicaltrialsregister.eu. A Phase 2b/3, randomised, double-blind, placebo-controlled, parallel-group, multicentre protocol to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (QUASAR). Identifier: 2018-004002-25. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004002-25/SE/ . Accessed April 2025. 7 Rubin, D. et al. Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis: QUASAR Phase 3 Double-Blind, Randomised, Placebo-Controlled Induction and Maintenance Studies. The Lancet. December 2024. Available at: https://doi.org/10.1016/S0140-6736(24)01927-5. 8 Allegretti, J, et al. The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active ulcerative colitis: Results from the Phase 3 QUASAR induction study. Presented at Digestive Disease Week, May 6-9. 9 Peyrin-Biroulet L, et al. Guselkumab in patients with moderately to severely active ulcerative colitis: QUASAR Phase 2b induction study. Gastroenterology. 2023 Dec;165(6):1443-1457. doi: 10.1053/j.gastro.2023.08.038. Epub 2023 Sep 1. PMID: 37659673. 10 Crohn’s & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis . Accessed April 2025. . 11 Schinocca, C. et al. Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview. Frontiers in immunology. 2021 Feb 22;12:321. Available at: https://doi.org/10.3389/fimmu.2021.637829. Accessed April 2025. 12 Turner D, Ricciuto A, Lewis A, et al; International Organization for the Study of IBD. STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD. Gastroenterology 2021; 160: 1570–83. 13 Johnson & Johnson Innovative Medicine. European Commission Approves Janssen’s TREMFYA®▼ (guselkumab), a First-in-Class Treatment for Active Psoriatic Arthritis (PsA). Available at: https://innovativemedicine.jnj.com/emea/european-commission-approves-janssens-tremfyarv-guselkumab-first-class-treatment-active-psoriatic . Accessed April 2025. 14 National Institutes of Health: ClinicalTrials.gov. A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis. Protocol CNTO1959UCO3001; Phase 2b/3 Amendment 3. Available at: https://cdn.clinicaltrials.gov/large-docs/45/NCT04033445/Prot_000.pdf . Accessed April 2025. 15 Atreya, R, et al. Guselkumab binding to CD64+ IL-23–producing myeloid cells enhances potency for neutralizing IL-23 signaling. J Crohns Colitis . 2024;18(suppl):S470. Accessed April 2025. 16 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 17 NHS. Overview Ulcerative colitis. Available at: https://www.nhs.uk/conditions/ulcerative-colitis/ . Accessed April 2025. 18 Barberio, B. et al. Prevalence of symptoms of anxiety and depression in patients with inflammatory bowel disease: a systematic review and meta-analysis. The Lancet Gastroenterology & Hepatology. 2021 May;6(5):359-370. Available at: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00014-5/abstract . 19 US Food and Drug Administration: Tremfya Product information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s009lbl.pdf . Accessed April 2025. 20 The Canadian Agency for Drugs & Technologies in Health. TREMFYA prescribing information. Available at: https://pdf.hres.ca/dpd_pm/00042101.pdf . Accessed April 2025. 21 Japan Pharmaceuticals and Medical Devices Agency. Tremfya report on the deliberation results. Available at: https://www.pmda.go.jp/files/000234741.pdf . Accessed April 2025. SOURCE: Johnson & Johnson

Phase 2Phase 3Drug ApprovalClinical Result

11 Apr 2025

·www.prnewswire.com

Weekly Recap: 15 Health Press Releases You Need to See

A roundup of the most newsworthy healthcare press releases from PR Newswire this week, including Google Cloud's commitment to AI-powered cancer research and Sun Pharma's partnership with a music icon. NEW YORK, April 11, 2025 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, April 7-11, 2025. Google Cloud and Ai2 Commit $20M to Advance AI-Powered Research for the Cancer AI Alliance Through the partnership, Google Cloud will power planet-scale AI infrastructure and data analytics tools, while Ai2 will provide critical expertise in training large-scale models focusing on cancer research. Music Icon Art Garfunkel Opens Up About His Experience with Psoriasis for The First Time in Partnership with Sun Pharma 8X Grammy Award-winning artist and Rock and Roll Hall of Fame inductee, Art Garfunkel, reveals his experience with ILUMYA® (tildrakizumab-asmn), stating, "I am finally ready to give my history with psoriasis a voice." H.I.G. Capital Completes Acquisition of GetixHealth "GetixHealth is a vital partner to healthcare providers, including many of the nation's largest health systems," says Anthony Chambers, Managing Director at H.I.G., referencing GetixHealth's revenue cycle management (RCM) solutions and comprehensive suite of services. CVS Health Announces Chief Financial Officer Transition Plan; Appoints Chief Medical Officer Brian Newman has been named executive vice president and chief financial officer designate, effective April 21. Amy Compton-Phillips, M.D., is the company's new executive vice president and chief medical officer, effective May 19. Breakthrough Prize Announces 2025 Laureates in Life Sciences, Fundamental Physics, and Mathematics "This year's Breakthrough Prize laureates have made amazing strides – including treatments for major diseases affecting millions of people worldwide – showing once again the transformative power of curiosity-driven basic science," said Priscilla Chan and Mark Zuckerberg. Proprio Receives FDA Clearance For the World's First AI Surgical Guidance Platform This is the first-ever technology that enables 3D, dynamic and segmental viewing of the anatomy, and marks the first time in history that surgeons will be able to measure success in real-time during surgery. Healthcare Brands to Gain Enhanced Engagement through CMI Media Group and Compas Collaboration with Microsoft Advertising "This represents a major milestone for the healthcare industry combining valuable expertise and reach. With this unique agreement, we can offer all of our clients expanded benefits to engaging with us for their search engine marketing and display investments," said Justin Freid, Chief Media & Innovation Officer, CMI Media Group. LG Expands Mental Health Support for NCAA Final Four Host Schools with NAMI Partnership The donation will enable each university's NAMI on Campus club to expand its programming, increase awareness of mental health resources and provide peer support for students facing challenges. In addition, each university will receive LG's innovative Counter-Depth MAX™ refrigerator with Zero Clearance™ for their student meeting spaces. Health Advocates Team-Up with #WearSunscreen Campaign to Spread the Word About Sun Safety "Just like brushing your teeth or clicking your seatbelt, wearing sunscreen should be a consistent part of your daily routine all year long," said Dr. Jane Yoo, a board-certified dermatologist and dermatologic surgeon in New York City. MADD and Nationwide Launch "Prom Promise" Campaign to Help Parents Prevent Underage Drinking This Prom Season At the heart of the Prom Promise campaign is MADD's Prom Promise Contract — an agreement parents and teens sign together to commit to a safe, substance-free prom night. Through this pledge, families establish clear expectations, boundaries, and a shared understanding of the serious risks associated with underage substance use and impaired driving. New Survey Reveals Nearly 75% of Nurses Unaware of Potential Health Risks in IV Bags Nearly 75% of nurses polled were unaware that the majority of IV bags used in the U.S. contain Di(2-ethylhexyl) Phthalate (DEHP), and more than 50% were unaware that the state of California has determined DEHP to be a reproductive and developmental toxicant and carcinogen. Quest Diagnostics Launches New AD-Detect™ Blood Test to Aid in Confirming Alzheimer's Disease "Quest's AD-Detect suite of advanced diagnostics has grown to include a range of validated blood-based biomarkers, giving providers options for personalizing testing for the individual patient," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. New Landmark Study Reveals Brain Blood Flow as Key Biomarker in Depression--Amen Clinics Plays Pivotal Role This landmark research demonstrates that functional brain changes—specifically decreased blood flow—are more accurate markers of depression than structural brain changes like cortical thinning, which have historically shown weak and inconsistent associations. AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. Biohaven Presents Data Across Innovative Neuroscience Portfolio at the 2025 American Academy of Neurology (AAN) Annual Meeting The presentations highlight Biohaven's innovative neuroscience pipeline across multiple early and late-stage development programs including Kv7 ion channel modulation, extracellular protein degradation, TRPM3 antagonism, TYK2/JAK1 inhibition, and glutamate modulation. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionPhase 3Clinical Result

04 Apr 2025

·www.prnewswire.com

Music Icon Art Garfunkel Opens Up About His Experience with Psoriasis for The First Time in Partnership with Sun Pharma

8X Grammy Award-winning artist and Rock and Roll Hall of Fame inductee reveals his experience with ILUMYA®(tildrakizumab-asmn) as part of the "I LUV YA for The Long Haul" campaign. PRINCETON, N.J., April 4, 2025 /PRNewswire/ -- Today, Sun Pharma announced its partnership with music icon and ILUMYA® (tildrakizumab-asmn) patient, Art Garfunkel, as he shares his story of living with moderate-to-severe plaque psoriasis in-depth for the first time publicly. Art, who was named one of Rolling Stone's "100 Greatest Singers of All Time," launched his career in the acclaimed duo "Simon & Garfunkel." Through the "I LUV YA for The Long Haul" campaign, Art joins a community of ILUMYA patients shedding light on the emotional toll of psoriasis and empowering others living with the condition to find the best treatment for them. While nearly 8 million Americans live with plaque psoriasis, its impact is often unseen or covered up.1 Art, whose music has touched millions worldwide, lived silently with his psoriasis—until now. "With support from my wife, Kim, and a treatment I trust, I am finally ready to give my history with psoriasis a voice," said Art. "After struggling for decades, I finally started ILUMYA about two years ago, and experiencing clearer skin has helped me regain my confidence. I am excited to share my story as part of the I LUV YA campaign in the hope that it will encourage others to find the right treatment for them." The "I LUV YA for The Long Haul," originally launched in May 2024, highlights the emotional impact psoriasis can have on a patient's life and how support – whether that be from a doctor, friend, or family member – can help navigate the challenges of managing their condition. The multi-part video series highlights real-life patient stories, including Art and how his wife, Kim, provided that support for him. "We are so honored to partner with Art Garfunkel to share his ILUMYA story and to bring greater awareness to the impact psoriasis has beyond the physical symptoms," said Maureen Shannon, Head of Biologics Marketing at Sun Pharma. "Art's music has impacted millions and his experience, shared for the first time, is sure to leave a lasting impression." To learn more about Art Garfunkel's experience and to learn more about ILUMYA as a treatment option, visit ILUMYA.com/ILuvYa. About Plaque Psoriasis Plaque psoriasis is a chronic, autoimmune disease that results in an overactive immune system and causes inflammation in the body, leading to symptoms like plaques, redness and flakes. It is estimated that nearly 8 million Americans live with plaque psoriasis.1 In plaque psoriasis, skin cells grow more rapidly than normal, rising to the surface of the skin in days rather than weeks. Life with plaque psoriasis can also be more than the physical symptoms – there can be an emotional impact as well. About ILUMYA (tildrakizumab-asmn) ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and Japan, and under the brand name ILUMETRI® in Europe, where it is marketed by Almirall. INDICATIONS AND USAGE ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hypersensitivity Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. Please see Full Prescribing Information. About Sun Pharmaceutical Industries Limited Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as Global Emerging Markets. Sun's high-growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit & follow us on LinkedIn & X (Formerly Twitter). Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References SOURCE Sun Pharmaceutical Industries Inc., USA (Sun Pharma) WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

100 Deals associated with Tildrakizumab-ASMN

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KEGG	Wiki	ATC	Drug Bank
-	Tildrakizumab-ASMN	L04AC	DB14004

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	United States	Sun Pharmaceutical Industries Ltd.	20 Mar 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Psoriasis	Phase 3	United States	Sun Pharmaceutical Industries Ltd.	01 Mar 2025
Psoriasis of nail	Phase 3	United States	Sun Pharmaceutical Industries Ltd.	13 May 2021
Psoriasis of nail	Phase 3	Australia	Sun Pharmaceutical Industries Ltd.	13 May 2021
Psoriasis of scalp	Phase 3	United States	Sun Pharmaceutical Industries Ltd.	29 Mar 2019
Psoriasis of scalp	Phase 3	Australia	Sun Pharmaceutical Industries Ltd.	29 Mar 2019
Arthritis, Psoriatic	Phase 3	Argentina	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Hungary	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Mexico	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Russia	Sun Pharmaceutical Industries Ltd.	29 Aug 2018
Arthritis, Psoriatic	Phase 3	Ukraine	Sun Pharmaceutical Industries Ltd.	29 Aug 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRNewswire Manual	Phase 3	Plaque psoriasis	99	ILUMYA	wndfsgkwdu(thqiqqwtfd) = yfusibroyj tizaqsunjc (rzqbwsunpk ) View more	Positive	07 Mar 2025
PRNewswire Manual	Phase 3	Plaque psoriasis	99	Placebo	wndfsgkwdu(thqiqqwtfd) = stbaxitrlg tizaqsunjc (rzqbwsunpk ) View more	Positive	07 Mar 2025
NCT03552276 (CTgov)	Phase 2/3	Arthritis, Psoriatic	281	Tildrakizumab (Tildrakizumab 200 mg q4 Weeks)	flrcrlzvvi = abhwxuskve fylqjxmgrz (bisoykghqb, nvdbihxoud - wajnvotryd)	-	21 Nov 2024
NCT03552276 (CTgov)	Phase 2/3	Arthritis, Psoriatic	281	Tildrakizumab (Tildrakizumab 200 mg q12 Weeks)	flrcrlzvvi = ghrmfrgoum fylqjxmgrz (bisoykghqb, auscegwvuq - nvswbogkck)	-	21 Nov 2024
Pubmed Manual	Not Applicable	Psoriasis	-	Tildrakizumab 200 mg	wjjvefbvyt(pzuukyevov) = pefkkpkobz wbnupngvdk (nyglhxfkve ) View more	Positive	27 Oct 2024
NCT04541329 (CTgov)	Phase 4	inflammatory dermatosis \| Psoriasis vulgaris	7	Tildrakizumab	vkpxcubbwy(rpdywlaody) = jamfkiaxqr eovkjehjvb (hkhasdeyqg, 4.1) View more	-	30 Apr 2024
NCT05108766 (Pubmed) Manual	Phase 3	Plaque psoriasis	220	Tildrakizumab 100 mg	cfoxckgrwj(ddmrxnfemt) = husgzidgkx kqkncnsmom (zokbghrqdt ) View more	Positive	09 Jan 2024
EADV2023	Not Applicable	SNPs	81	Tildrakizumab	diclwjutgk(toxfhllifk) = xtjsbclxub bkgankzrzb (xseltuhmbh ) View more	-	11 Oct 2023
EADV2023	Not Applicable	-	1,078	Tildrakizumab 100 mg	sttfgvqeiu(xfshbianew) = goyfcswyku nruzdxcxgb (dinfevgvxc, 82.1 - 86.9)	Positive	11 Oct 2023
EADV2023	Not Applicable	-	1,078	Tildrakizumab 200 mg	sttfgvqeiu(xfshbianew) = ifqzxsmfpf nruzdxcxgb (dinfevgvxc, 88.4 - 92.5)	Positive	11 Oct 2023
EADV2023	Not Applicable	-	51	Tildrakizumab 100 mg	wmvhckhofg(qxsjfosaoz) = no adverse event was reported by our patients during the whole 12-week follow-up period bswcogkveq (uwbfmqdaxk )	Positive	11 Oct 2023
NCT04229836 (TRIBUTE, EADV2023)	Phase 4	Plaque psoriasis	177	Tildrakizumab 100 mg	wezeifcqfz(ujnwjvkcux) = a greater BSA affected at baseline could be argued wacggvaolm (klazxiomfr ) View more	Positive	11 Oct 2023
TILOT (EADV2023)	Not Applicable	Plaque psoriasis	503	Tildrakizumab 100 mg (s.c.)	yeojfctopb(vwsgyvkaws) = bbytkiuuzk guhtffikrh (ydcyiepqno ) View more	Positive	11 Oct 2023
TILOT (EADV2023)	Not Applicable	Plaque psoriasis	503	Placebo	yeojfctopb(vwsgyvkaws) = hakcwzzwqd guhtffikrh (ydcyiepqno ) View more	Positive	11 Oct 2023

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