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

Dow Jones05-25

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 ben.glickman@wsj.com

(END) Dow Jones Newswires

May 24, 2024 15:30 ET (19:30 GMT)

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