Sobi North America Gets FDA Fast Track Designation for Rheumatic Disease Complication Treatment

By Ben Glickman

Sobi North America said it had received fast track designation from U.S. regulators for its potential treatment for Macrophage Activation Syndrome, a complication of rheumatic diseases.

The Waltham, Mass.-based affiliate of Swedish Orphan Biovitrum said Friday that the U.S. Food and Drug Administration had granted the designation to emapalumab-lzsg, a monoclonal antibody. The compound is currently the only medicine approved in the U.S. for primary haemophagocytic lymphohistiocytosis, a syndrome of hyperinflammation also known as HLH, according to Sobi.

MAS, a form of HLH, is characterized by fever, liver dysfunction and other symptoms.

Emapalumab is currently in phase 3 development for treating MAS.

Write to Ben Glickman at [e-mail]

(END) Dow Jones Newswires

05-24-24 1545ET