US FDA thumbs up for Takeda’s Entyvio for ulcerative colitis and Crohn's disease
The US Food and Drug Administration yesterday approved Entyvio (vedolizumab) injection, from Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502), to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn‘s disease.
Entyvio is approved to treat those conditions when one or more standard therapies (corticosteroids, immunomodulators, or tumor necrosis factor blocker medications) have not resulted in an adequate response. The FDA decision comes soon after a European Medicines Agency advisory committee recommendation to approve Entyvio for the same indications (The Pharma Letter March 21).
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