FDA Approves Entyvio for Ulcerative Colitis, Crohn's
To treat patients for whom corticosteroids or tumor necrosis factor-blocking medications have failed
WEDNESDAY, May 21, 2014 (HealthDay News) -- Entyvio (vedolizumab) has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe forms of two gastrointestinal conditions -- ulcerative colitis and Crohn's disease.
The approval applies to people for whom standard therapies -- such as corticosteroids or tumor necrosis factor-blocking medications -- have failed.
The most common side effects of Entyvio include headache, joint pain, nausea, and fever. More serious adverse reactions observed during clinical testing included serious infection and allergy-like (hypersensitivity) reaction.
Though no clinical trial participants contracted a rare, often-fatal nervous system infection called progressive multifocal leukoencephalopathy (PML), the FDA said Entyvio users should be monitored for neurological signs of PML.
Entyvio is marketed by Takeda Pharmaceuticals America, based in Deerfield, Ill.