Gamifant, a fully human, IFNγ-blocking monoclonal antibody, was approved by the
Since its approval, no study has evaluated the use of Gamifant in a larger cohort of patients in the real-world clinical setting.
“We look forward to presenting real-world data about the clinical characteristics and treatment patterns in a subset of patients with secondary HLH who were treated with Gamifant from the REAL-HLH study in a poster presentation at ACR,” said Dr.
Currently, Gamifant is not approved by the FDA for the treatment of patients with secondary HLH.
Sobi presentation at the ACR Convergence 2022 Meeting:
Poster Title: Real-World Demographics, Clinical Characteristics, and Treatment Patterns of Patients Treated with Emapalumab for Secondary Hemophagocytic Lymphohistiocytosis in
Author:
Abstract Number: 0740
Session: Poster Session B
Presentation Date/Time:
About Gamifant®
Gamifant (emapalumab-lzsg) is an interferon gamma (IFNγ) blocking monoclonal 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.
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). This was the first treatment approved for patients with HLH by the FDA and followed the agency’s granting the applications for Priority Review and Breakthrough Therapy designation.
In
Important Safety Information
Gamifant can cause serious side effects, including infections. Gamifant may increase the risk of serious infections that can lead to death. These infections include tuberculosis (TB), histoplasmosis, herpes zoster infection (shingles), and other infections caused by viruses, fungi, or bacteria that can spread throughout the body. Infections are common in people treated with Gamifant. Before initiating Gamifant, prophylaxis should be provided to help prevent certain infections. Do not administer live or live attenuated vaccines to patients receiving Gamifant and for at least four weeks after the last dose of Gamifant.
Gamifant can cause serious infusion reactions. These are common, can also be severe, and can happen during or shortly after treatment with Gamifant.
In the pivotal trial, the most commonly reported adverse reactions (≥10%) for Gamifant included infection, hypertension, infusion-related reactions, pyrexia, hypokalemia, constipation, rash, abdominal pain, CMV infection, diarrhea, lymphocytosis, cough, irritability, tachycardia, and tachypnea.
These are not all the possible side effects for Gamifant. For more information, please see the Full Prescribing Information for Gamifant.
To report suspected adverse reactions, contact
About Sobi in
As the North American affiliate of international biopharmaceutical company Sobi, our team is committed to Sobi’s vision of providing access to innovative treatments that make a significant difference in the lives of individuals with rare diseases. Our product portfolio includes multiple approved treatments, focused on inflammation/immunology and genetics/metabolism. With
Contacts
For the Sobi NA Medical team, please contact medinfo.us@sobi.com. For Sobi media contacts, click here.
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