Sobi to Present Data from REAL-HLH Study at the ACR Convergence 2022 MeetingData presented from the REAL-HLH study; the first study of patients treated with Gamifant in a real-world clinical setting

WALTHAM, Mass., Oct. 27, 2022 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of the Swedish Orphan Biovitrum AB (publ) (Sobi®) (STO:SOBI), a specialized international biopharmaceutical company transforming the lives of people with rare diseases, today announced a presentation from the REAL-HLH study – a chart review study which assessed real-world treatment patterns and outcomes in patients with hemophagocytic lymphohistiocytosis (HLH) who were treated with Gamifant® (emapalumab-lzsg) – at the American College of Rheumatology Convergence 2022 Meeting taking place in Philadelphia from November 10-14, 2022.

Gamifant, a fully human, IFNγ-blocking monoclonal antibody, was approved by the U.S. Food and Drug Administration in 2018 for the treatment of adult and pediatric patients with primary HLH (pHLH) with refractory, recurrent or progressive disease or intolerance to conventional therapy. This FDA approval was the first and only for a treatment specifically for HLH.

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. John Yee, MD, MPH, Chief Medical Officer, Sobi North America.

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 the United States: The REAL-HLH Study
Author: Carl Allen, et al.
Abstract Number: 0740
Session: Poster Session B
Presentation Date/Time: Sunday, November 13, 2022, 9:00 AM-10: 30 AM EST

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 September 2020, Gamifant received Orphan Drug Designation (ODD) by the FDA for prevention of graft failure following hematopoietic stem cell transplantation.

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 Sobi North America at 1-866-773-5274 or FDA at 1-800-FDA-1088.

About Sobi in North America
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 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 www.sobi-northamerica.com or at www.sobi.com.

Contacts
For the Sobi NA Medical team, please contact medinfo.us@sobi.com. For Sobi media contacts, click here.