BIOVF - European advisory group affirms rejection of Swedish Orphan's Gamifant for rare inflammatory disorder

After re-examining its its initial negative opinion issued in July, the European Medicines Agency's advisory group CHMP maintains its position against approving Swedish Orphan Biovitrum AB's (BIOVF) Gamifant (emapalumab) for the treatment of primary hemophagocytic lymphohistiocytosis, a rare inherited inflammatory condition in which the body produces excessive amounts of immune cells.CHMP says the data from a small study were insufficient to demonstrate effectiveness.

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European advisory group affirms rejection of Swedish Orphan's Gamifant for rare inflammatory disorder