Gamifant faces challenges in Europe

By Brian Buntz | July 21, 2021

Gamifant Sobi Gamifant from Sobi, Inc. is an interferon gamma (IFNγ) blocking antibody that is FDA-indication to treat adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH). The indication covers refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

First approved in the U.S. in 2018, Gamifant has run into regulatory roadblocks in Europe. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has twice issued negative opinions related to the drug.

Filed Under: Immunology
Tagged With: Gamifant, hemophagocytic lymphohistiocytosis, interferon gamma, primary hemophagocytic lymphohistiocytosis

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.