EMBRACE is a double-blind, randomized, placebo-controlled, phase IIa study that will be conducted in multiple Intensive Care Units (ICUs) and departments of Internal Medicine across Greece. It aims to investigate if treatment with emapalumab, a monoclonal antibody which blocks IFNγ, may improve the outcome of patients with sepsis driven by the IDS (endotype of IFNγ-driven sepsis) endotype. EMBRACE also aims to identify the best dosing regimen of emapalumab for the management of IDS.

Start Date01 Nov 2024

Sponsor / Collaborator

Hellenic Institute for the Study of Sepsis

NCT06550141 / Not yet recruitingPhase 2IIT

A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities

This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).
The research study involves the following study interventions:
* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)
* Axicabtagene Ciloleucel
* Emapalumab

Start Date01 Aug 2024

Sponsor / Collaborator

The General Hospital Corp.

[+1]

NCT06285825 / RecruitingPhase 2IIT

A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia

To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.

Start Date05 Jul 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Emapalumab-LZSG

100 Translational Medicine associated with Emapalumab-LZSG

100 Patents (Medical) associated with Emapalumab-LZSG

Literatures (Medical) associated with Emapalumab-LZSG

01 Dec 2024·ANNALS OF THE RHEUMATIC DISEASES

Efficacy and safety of therapies for Still’s disease and macrophage activation syndrome (MAS): a systematic review informing the EULAR/PReS guidelines for the management of Still’s disease

Review

Author: Fautrel, Bruno ; Mitrovic, Stéphane ; Bindoli, Sara ; De Matteis, Arianna ; Carmona, Loreto ; De Benedetti, Fabrizio

Objectives:

To analyse the efficacy and safety of treatments for Still’s disease and macrophage activation syndrome (MAS).

Methods:

Medline, Embase and Cochrane Library were searched for clinical trials (randomised, randomised controlled trial (RCT), controlled and clinical controlled trial (CCT)), observational studies (retrospective, longitudinal observational retrospective (LOR), prospective and longitudinal observational prospective (LOP)) and systematic reviews (SRs), in which the populations studied were patients with Still’s disease and MAS. The intervention was any pharmacological treatment (approved or under evaluation) versus any comparator drug or placebo, and as outcomes, any relevant efficacy and safety event. The risk of bias (RoB) was assessed with the Cochrane RoB and AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews-2, version 2) for SRs.

Results:

128 full texts were included: 25 RCTs, 1 CCT, 11 SRs published after 2013 and 91 LOP/LOR studies. In Still’s disease, interleukin (IL)-1 inhibitors (IL-1i) and IL-6R inhibitors (IL-6i) were the most studied drugs. Two meta-analyses on RCTs showed an OR, to achieve an ARC50 response rate, of 6.02 (95% CI 2.24 to 21.36) and 8.08 (95% CI 1.89 to 34.57) for IL-1i and IL-6Ri, respectively. Retrospective studies showed that early initiation of IL-1i or IL-6i was associated with high rates of clinically inactive disease. In MAS, GCs were employed in all patients, often associated with ciclosporin and/or anakinra. Rates of complete response were reported, with a range from 53% to 100%. Emapalumab was the only drug tested in a CCT, with a complete response of 93%.

Conclusion:

IL-1i and IL-6Ri show the highest level of efficacy in the treatment of Still’s disease. For MAS, IL-1 and interferon-γ inhibition appear to be effective on a background of high-dose glucocorticoids.

27 Sep 2024·MEDICINE

Emapalumab as a therapeutic intervention for Epstein–Barr virus-associated hemophagocytic lymphohistiocytosis: A case series

Article

Author: Yu, Li ; Pei, Fuyu ; Yuan, Xiao ; Wang, Wen

Rationale::

Epstein–Barr virus-associated hemophagocytic lymphohistiocytosis (EBV-HLH) is characterized by a severe cytokine storm, heightened inflammatory response, and immune-mediated damage to tissues and organs. Standard treatment protocols for hemophagocytic lymphohistiocytosis often fall short in effectively controlling EBV-HLH, leading to a need for novel therapeutic options. Emapalumab, a monoclonal antibody targeting interferon-gamma, has shown promise due to its targeted cytokine modulation capabilities and favorable safety profile. This study aimed to evaluate the efficacy and safety of emapalumab in pediatric patients with EBV-HLH.

Patient concerns::

The case series involved 4 pediatric patients diagnosed with EBV-HLH who did not achieve disease control despite receiving comprehensive treatment.

Diagnoses::

All 4 pediatric patients were diagnosed with EBV-HLH.

Interventions::

Emapalumab was introduced as an adjunctive therapeutic intervention alongside the HLH-94 or L-DEP regimens for these patients.

Outcomes::

Among the 4 patients, 1 experienced severe multiorgan dysfunction and opted to discontinue therapy. The remaining 3 patients showed controlled disease progression with significant clinical improvements following emapalumab administration. These improvements included reduced levels of inflammatory markers, normalization of blood counts and liver function, and decreased Epstein–Barr virus viral load.

Lessons::

The findings suggest that emapalumab may be an effective and safe treatment option for pediatric EBV-HLH. However, further research is necessary to confirm these outcomes, especially in critically ill patients.

01 Sep 2024·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Systemic T-cell activation and IFN-γ activity in indeterminate severe hepatitis are reminiscent of hemophagocytic lymphohistiocytosis: Implications for T-cell– and IFN-γ–directed therapies

Article

Author: Kapoor, Urvi ; Montminy, Taylor ; Chandrakasan, Shanmuganathan ; Prince, Chengyu ; Rytting, Heather B ; Satwani, Prakash ; Goldner, Dana ; Malik, Sakshi ; Remotti, Helen E. ; Nguyen, Thinh H. ; Fazlollahi, Ladan ; Marsh, Rebecca ; Romero, Rene ; Rytting, Heather B. ; Remotti, Helen E ; Nguyen, Thinh H ; Martinez, Mercedes ; Smiley, Kristi ; Kumar, Deepak

BACKGROUND:

Severe hepatitis cases in children are increasingly recognized, but the exact etiology remains unknown in a significant proportion of patients. Cases of indeterminate severe hepatitis (iSH) may progress to indeterminate pediatric acute liver failure (iPALF), so understanding its immunobiology is critical to preventing disease progression. Hemophagocytic lymphohistiocytosis (HLH) is a systemic hyperinflammatory disorder associated with T-cell and macrophage activation with liver injury.

OBJECTIVES:

We hypothesized that a high proportion of patients with iSH demonstrate systemic T-cell activation similar to HLH before developing iPALF and that the degree of T-cell activation in iSH might correlate with outcomes.

METHODS:

From 2019 to 2022, 14 patients with iSH and 7 patients with PALF of known, nonimmune etiology were prospectively enrolled. We compared immune signatures of iSH, HLH, known PALF, and healthy controls.

RESULTS:

We found that patients with iSH have increased CD8⁺ T-cell activation and high IFN-γ activity similar to HLH. The amplitude of CD8⁺ T-cell activation was predictive of iSH progression to iPALF. We also found that in patients with iSH, ferritin had only modest elevation. However, the ratio of age-normalized plasma soluble IL-2 receptor to ferritin level can distinguish iSH from known PALF and HLH. As proof of concept, we report that in 3 patients with steroid-refractory iSH, emapalumab, an IFN-γ blocking antibody used in combination with steroids, improved liver function and may have prevented progression to PALF.

CONCLUSIONS:

Flow-based T-cell activation markers could help in early identification and risk stratification for targeted intervention in patients with iSH.

News (Medical) associated with Emapalumab-LZSG

07 Nov 2024

·www.globenewswire.com

Sobi to present new data across its immunology portfolio at the ACR Convergence 2024

WALTHAM, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced the presentation of four abstracts that highlights data from its immunology portfolio at the ACR Convergence 2024 taking place in Washington, D.C. from November 14–19, 2024. Sobi’s commitment to delivering innovative treatments for people living with immunological diseases is seen in global studies spanning multiple disorders: Results from two Phase 3 trials evaluating the effect on patient-reported outcomes in patients with chronic refractory gout treated with SEL-212.Initial data on the effect of anti-drug antibodies on serum uric acid (sUA) reduction and safety in response to treatment with SEL-212.DISSOLVE 1 Phase 3 study: Results of a post hoc analysis of sustained sUA reduction and safety of SEL-212 in patients with chronic refractory gout living in the United States.Results from a Phase 3 Study and a pooled analysis of two prospective trials evaluating efficacy and safety of emapalumab in patients with Macrophage Activation Syndrome in Still’s disease. Key Sobi data to be presented at ACR Convergence 2024 Chronic Refractory GoutSEL-212Improvements in Patient-Reported Outcomes After Treatment with SEL-212 in Adults with Refractory Gout: Results from Two Randomized Phase 3 TrialsSession: Patient Outcomes, Preferences, & Attitudes Poster ISaturday, November 16; 10:30 AM - 12:30 PMImpact of Anti-drug Antibodies on the Efficacy of SEL-212 in Patients with Chronic Gout Refractory to Conventional TherapySafety and Efficacy of SEL-212 in the US and ex-US Subgroups: Results from the Phase 3 DISSOLVE StudiesSession: Metabolic & Crystal Arthropathies – Basic & Clinical Science Poster IIIMonday, November 18; 10:30 AM - 12:30 PM Macrophage Activation SyndromeEmapalumabEfficacy and Safety of Emapalumab in Children and Adults with Macrophage Activation Syndrome (MAS) in Still’s disease: Results from a Phase 3 Study and a Pooled Analysis of Two Prospective TrialsLate-Breaking AbstractsNovember 19; Session Time: 8:00 AM - 9:30 AM; Presentation Time: 9:00 AM - 9:15 AM All abstracts can be accessed via the official ACR Convergence website. ContactsFor details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media, click here. About SEL-212SEL-212 is being developed as a novel once-monthly combination medicine that integrates targeted immunomodulation with uricase-based therapy and is being investigated for the treatment of chronic refractory gout . SEL-212 consists of pegadricase, a proprietary pegylated uricase, co-administered with nanoencapsulated sirolimus. About Chronic Refractory GoutGout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 160,000 people in the United States suffer from chronic refractory gout (CRG), where patients are resistant to conventional medicines and symptoms are more persistent. CRG is a painful and debilitating condition in people with persistent raised serum uric acid (sUA) levels, which may result in several flares per year and the development of nodular masses of uric acid crystals known as tophi. About emapalumab-lzsgEmapalumab-lzsg is a fully human, anti-IFNγ monoclonal antibody that binds free and receptor-bound IFNγ, neutralizing its biological activity. In the US, emapalumab-lzsg is indicated for pediatric (newborn and older) and adult primary hemophagocytic lymphohistiocytosis (HLH) patients with refractory, recurrent or progressive disease, or intolerance to conventional HLH therapy. Emapalumab-lzsg is the first and only medicine approved in the US for primary HLH, a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval in 2018 was based on data from the phase 2/3 studies (NCT01818492 and NCT02069899).For the treatment of HLH, Emapalumab is indicated for administration through twice per week until hematopoietic stem cell transplantation (HSCT). The efficacy and safety of emapalumab are currently being evaluated. Emapalumab is currently under investigation (phase 3) in patients with MAS in Still’s disease or systemic lupus erythematosus (SLE) (EMERALD; NCT05001737). U.S. Indication for Gamifant® (emapalumab-lzsg)Gamifant® (emapalumab-lzsg) is an interferon gamma (IFNγ)–blocking antibody indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy. Important Safety InformationInfectionsBefore initiating Gamifant, patients should be evaluated for infection, including latent tuberculosis (TB). Prophylaxis for TB should be administered to patients who are at risk for TB or known to have a positive purified protein derivative (PPD) test result or positive IFNγ release assay. During Gamifant treatment, patients should be monitored for TB, adenovirus, Epstein-Barr virus (EBV), and cytomegalovirus (CMV) every 2 weeks and as clinically indicated. Patients should be administered prophylaxis for herpes zoster, Pneumocystis jirovecii, and fungal infections prior to Gamifant administration. Increased Risk of Infection With Use of Live VaccinesDo not administer live or live attenuated vaccines to patients receiving Gamifant and for at least 4 weeks after the last dose of Gamifant. The safety of immunization with live vaccines during or following Gamifant therapy has not been studied. Infusion-Related ReactionsInfusion-related reactions, including drug eruption, pyrexia, rash, erythema, and hyperhidrosis, were reported with Gamifant treatment in 27% of patients. In one-third of these patients, the infusion-related reaction occurred during the first infusion. Adverse ReactionsIn the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection (56%), hypertension (41%), infusion-related reactions (27%), pyrexia (24%), hypokalemia (15%), constipation (15%), rash (12%), abdominal pain (12%), CMV infection (12%), diarrhea (12%), lymphocytosis (12%), cough (12%), irritability (12%), tachycardia (12%), and tachypnea (12%). Additional selected adverse reactions (all grades) that were reported in less than 10% of patients treated with Gamifant included vomiting, acute kidney injury, asthenia, bradycardia, dyspnea, gastrointestinal hemorrhage, epistaxis, and peripheral edema. Please see the full Prescribing Information for Gamifant. About Sobi North AmericaAs the North American affiliate of international biopharmaceutical company Sobi, the Sobi North America team is committed to Sobi’s vision of being a leader in providing innovative treatments that transform lives for individuals with rare diseases. Our product portfolio includes multiple approved treatments focused on immunology, hematology and specialty care. With U.S. headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at https://www.sobi.com/usa or at www.sobi.com. About Sobi®Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of hematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com, LinkedIn and YouTube. Brian Castellibrian.castelli@sobi.com

Phase 3Clinical ResultDrug ApprovalImmunotherapyVaccine

30 Oct 2024

·www.prnewswire.com

New data for emapalumab in the treatment of macrophage activation syndrome to be presented at the ACR conference

STOCKHOLM, Oct. 30, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that new research showing the effect of emapalumab in patients with macrophage activation syndrome (MAS) in Still's disease, including systemic juvenile idiopathic arthritis (sJIA) and adult-onset still's disease (AOSD) who had an inadequate response to high-dose glucocorticoids (GCs) will be presented at the American College of Rheumatology (ACR) Convergence in Washington D.C. The data were pooled from two open-label, single-arm interventional studies, the phase 3 NI-0501-14 study [EMERALD; NCT05001737] and NI-0501-06 [NCT03311854], including 39 patients with MAS. Key results: Complete response at week 8: At week 8, 21 patients (53.8%) achieved a complete response (95% confidence interval (CI): 37.2–69.9%). Complete response at any time: 33 patients (85%) achieved a complete response at any time during the studies. Glucocorticoid tapering: Weekly mean glucocorticoid doses were reduced by 70.1% after 2 weeks of treatment. By week 8, glucocorticoids were tapered to a clinically meaningful dose of ≤1 mg/kg/day in 28 patients (72%) and to ≤0.5 mg/kg/day in 17 patients (44%). Safety: No new safety concerns were identified during the studies. "MAS in Still's disease is a severe condition characterised by intense hyperinflammation and multiple organ failure. Those affected, including young children, often experience high fevers, liver and spleen enlargement, severe cytopenias, and neurological symptoms," said Lydia Abad-Franch, MD, Head of Research & Development and Medical Affairs and Chief Medical Officer at Sobi. "The results to be presented at ACR indicate that emapalumab could potentially provide a new therapeutic option, offering effective control of MAS symptoms and possibly reducing the need for high-dose glucocorticoids. This represents an important development in the treatment landscape for MAS." Additional key results: Overall response (OR) by week 8: 32 patients (82.4%) achieved an overall response by week 8. OR was observed as early as day 5, with a median time to first OR of 2.3 weeks. Clinical MAS remission: 32 patients (82.1%) achieved investigator-assessed clinical MAS remission at any time , with a median time to clinical remission of 3.3 weeks. Survival rate: 37 patients (94.9%) were alive at week 8. Emapalumab is a monoclonal antibody that neutralises interferon gamma (IFNγ), a key cytokine which contributes to the inflammation and tissue damage seen in MAS. The purpose of these two prospective studies is to assess the efficacy and safety of emapalumab in controlling MAS in patients with Still's disease, including sJIA and AOSD, who had an inadequate response to high-dose glucocorticoids. In May 2024, the US FDA granted emapalumab fast track designation as a potential therapeutic option in patient with MAS. Sobi plans to submit an sBLA for this indication to the FDA in 2024. The data will be presented by Alexei A. Grom, MD, Professor of Paediatrics, Research Director Division of Rheumatology, Cincinnati Children's Hospital Medical Centre, in a session entitled "Efficacy and Safety of emapalumab in children and adults with macrophage activation syndrome (MAS) in Still's disease: Results from a phase 3 study and a pooled analysis of two prospective trials" on Tuesday, 19 November at ACR Convergence. About macrophage activation syndrome (MAS) Macrophage activation syndrome (MAS) is a severe complication of rheumatic diseases, most frequently systemic juvenile idiopathic arthritis (sJIA) – a rare systemic disorder of auto-inflammatory nature with common clinical manifestations such as daily spiking fever, typical transient cutaneous rash, arthritis, lymphadenopathy, hepatosplenomegaly and serositis. MAS is characterised by fever, hepatosplenomegaly, liver dysfunction, cytopenias, coagulation abnormalities and hyperferritinaemia, possibly progressing to multiple organ failure and death. MAS is classified as a secondary form of haemophagocytic lymphohistiocytosis (HLH). About emapalumab Emapalumab (Gamifant®) is an anti-interferon gamma (IFNγ) monoclonal antibody that binds to and neutralises IFNγ. In the USA, emapalumab is indicated for the treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Primary HLH is a rare syndrome of hyperinflammation that usually occurs within the first year of life and can rapidly become fatal unless diagnosed and treated. The FDA approval is based on data from the phase 2/3 studies (NCT01818492 and NCT02069899). Gamifant is indicated for administration through intravenous infusion over one hour twice per week until haematopoietic stem cell transplantation (HSCT). About Sobi® Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia, and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Fast TrackDrug Approval

24 Oct 2024

·www.prnewswire.com

Sobi Q3 2024 report: Strong growth and significant pipeline momentum

STOCKHOLM, Oct. 24, 2024 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi®) today announced its report for the third quarter 2024 Third Quarter 2024 Total revenue increased 33 per cent, 39 per cent at constant exchange rates, (CER)1, to SEK 6,894 M (5,168) Haematology revenue increased 18 per cent at CER to SEK 4,000 M (3,484), mainly driven by strong sales of Doptelet® of SEK 1,039 M (650), sales of Aspaveli®/Empaveli® of SEK 270 M (169) and launch sales of Altuvoct® of SEK 129 M (—) Immunology revenue increased 96 per cent at CER to SEK 2,583 M (1,400), driven by strong Beyfortus® royalty of SEK 1,478 M (263) and sales of Kineret® of SEK 699 M (600) Revenue from medicines in the strategic portfolio* grew by 113 per cent at CER to SEK 3,830 M (1,924) The adjusted EBITA margin1,2 was 43 per cent (30), excluding items affecting comparability (IAC)2. EBITA was SEK 2,923 M (1,443), corresponding to a margin of 42 per cent (28). EBIT was SEK 2,038 M (547) Earnings per share (EPS) before dilution was SEK 4.27 (0.30). Adjusted EPS before dilution1 was SEK 4.36 (0.54). Cash flow from operating activities was SEK 1,201 M (1,058) In August, Sobi and Apellis Pharmaceuticals announced positive topline results from the Phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN Outlook 2024 - Updated Revenue is anticipated to grow by a mid-teens percentage at CER (previously low double-digit) The adjusted EBITA margin is anticipated to be in the mid-30s percentage of revenue (unchanged) Click here for the Financial Summary. Alternative Performance Measures (APMs). Items affecting comparability (IAC). * The strategic portfolio includes Sobi's medicines Altuvoct, Aspaveli/Empaveli, Doptelet, Gamifant®, Vonjo® and Zynlonta®, and royalty on Sanofi's sales of Altuviiio® and Beyfortus. Investors, analysts, and the media are invited to a conference call on the same day at 14:00 CEST, 13:00 BST, and 08:00 EDT. The call will include a presentation of the results and a Q&A session. The presentation can be followed live here or afterwards on sobi.com. The slides will be made available on sobi.com before the conference call. To participate in the conference call, please use the following dial-in details: Sweden: +46 8 5051 0031 United Kingdom: +44 207 107 06 13 United States: +1 631 570 56 13 For other countries, please find the details here. Sobi Sobi® is a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases. Providing reliable access to innovative medicines in the areas of haematology, immunology and specialty care, Sobi has approximately 1,800 employees across Europe, North America, the Middle East, Asia and Australia. In 2023, revenue amounted to SEK 22.1 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn. For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information is information that Sobi is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CEST on 24 October 2024. Gerard Tobin Head of Investor Relations This information was brought to you by Cision The following files are available for download: SOURCE Swedish Orphan Biovitrum AB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementClinical ResultPhase 3Biosimilar

100 Deals associated with Emapalumab-LZSG

External Link

KEGG	Wiki	ATC	Drug Bank
-	Emapalumab-LZSG	L04AA39	DB14724

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Lymphohistiocytosis, Hemophagocytic	US	Novimmune SA	20 Nov 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immune System Diseases	NDA/BLA	EU	Swedish Orphan Biovitrum AB	23 Jul 2020
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	US	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	JP	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	BE	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	CA	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	CZ	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	FR	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	DE	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	IT	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022
Polyarticular Juvenile Idiopathic Arthritis	Phase 3	NL	Supi Pharmaceutical (Guangzhou) Co., Ltd.	14 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2024	Not Applicable	-	-	Emapalumab	owjdzgzunx(nvrwyvdhpk) = ghwgalfhgi fjpclomsyn (rywwwfuocy )	-	01 Feb 2024
NCT04765553 (CTgov)	Phase 1	Rare Diseases	8	NI-0501 (Emapalumab)	uvpnoixxgl(nzelupuyja) = azcskeazwv kpszvxcdgc (qjezjbyabb, lmqtuvcrki - uvlyznwycj) View more	-	24 Nov 2023
NCT04765553 (CTgov)	Phase 1	Rare Diseases	8	Saline (Placebo)	egclfbqqyx(xhieplgcjt) = frwwecbfbm jgkhfmgwiq (yesuvpfvmz, mgsmlmgxaz - tsvrmyopiq) View more	-	24 Nov 2023
NCT03985423 (CTgov)	Phase 2/3	Lymphohistiocytosis, Hemophagocytic	7	Emapalumab-Lzsg	gcldfxyheo(uzghhzsmjg) = aihmfaxgut lpbsdkaqwp (nwjueldyhr, lalkwmvxsi - tzopojtxex) View more	-	06 Oct 2023
P353 (EBMT2023)	Phase 2	IFNÎ³ \| CXCL9	1	Emapalumab 3 mg/kg	mbbjedcedp(onuhdawiwk) = jaejzsjxqo youanioztj (oxtwqtvojz ) View more	Positive	23 Apr 2023
NCT02069899 (NI-0501-04 and NI-0501-05 \| ###DELETE, CTgov)	Phase 2/3	Lymphohistiocytosis, Hemophagocytic	58	Emapalumab (Enrolled-04 Cohort)	istkyzmfla(jevclndvkq) = zcothyovbr alkttfrhuv (rqtomimqbg, dcghgjigcw - jleukesecq) View more	-	28 Jun 2022
NCT02069899 (NI-0501-04 and NI-0501-05 \| ###DELETE, CTgov)	Phase 2/3	Lymphohistiocytosis, Hemophagocytic	58	emapalumab (Enrolled-06 Cohort)	istkyzmfla(jevclndvkq) = xbrssqkqja alkttfrhuv (rqtomimqbg, dlwwmcnotm - cppvemyoqr) View more	-	28 Jun 2022
NCT04731298 (P449, EBMT2022)	Phase 2	Primary Graft Dysfunction CXCL9	10	Emapalumab	glwnoqscdj(ujzxjrzozk) = kfsmfdkuru yrnznyjbju (uzdtvzppol ) View more	Positive	19 Mar 2022
NCT02069899 \| NCT01818492 (Tandem Meetings ASTCT and CIBMTR2021)	Phase 2/3	Lymphohistiocytosis, Hemophagocytic Second line	45	Emapalumab 1 mg/kg	zlmgdcsqcz(jlhesyazvi) = tgugmqstpd mxhtkpclqx (fozfhyksjg, 68.3 - 97.6) View more	Positive	01 Mar 2021
	Phase 2/3	Lymphohistiocytosis, Hemophagocytic Second line	45	Background dexamethasone 5-10 mg/m2	zlmgdcsqcz(jlhesyazvi) = iibjfhpgfa mxhtkpclqx (fozfhyksjg, 62.1 - 92.1) View more	Positive	01 Mar 2021
NCT02069899 \| NCT01818492 (NI-0501-04 \| NI-0501-05, Pubmed \| Br Dent J) Manual	Phase 2/3	Lymphohistiocytosis, Hemophagocytic First line	34	Emapalumab (previously treated)	ofgtgeikzv(smvhlsbrnw) = tvibbukbgf hadmrabjdn (bezwgppsxs ) View more	Positive	07 May 2020
	Phase 2/3	Lymphohistiocytosis, Hemophagocytic First line	34	Emapalumab (previously untreated)	ofgtgeikzv(smvhlsbrnw) = yhcdspcpgk hadmrabjdn (bezwgppsxs ) View more	Positive	07 May 2020
NI-0501 (ACR2015)	Not Applicable	Lymphohistiocytosis, Hemophagocytic IFNg	10	NI-0501 1 mg/kg	hcslcjjqjw(qqyegbaucu) = All infusions were well tolerated and no safety concerns emerged gviecixitv (csbfdrbpxw )	Positive	10 Nov 2015
NI-0501 (ACR2015)	Not Applicable	Lymphohistiocytosis, Hemophagocytic \| Autoinflammation With Infantile Enterocolitis IL-18 \| IFNγ \| CXCL9 ... View more	1	NI-0501	gzkgridqxk(jffrlqrdoj) = zidairwkow kbjqqsbkgd (vsnfaqqfns )	Positive	10 Nov 2015

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Bio Sequences Search & Analysis

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Chemical Structures Search & Analysis