FDA Approves New Drug for Crohn Disease and Ulcerative Colitis

By Kristin J. Kelley

The FDA has approved vedolizumab, an injectable monoclonal antibody, to treat adults with moderate-to-severe Crohn disease and ulcerative colitis (UC). The drug, marketed as Entyvio, is indicated for patients who have not responded well to one or more conventional therapies (e.g., corticosteroids, immunomodulators, tumor necrosis factor inhibitors).

Vedolizumab, an integrin receptor antagonist, provides an alternative to natalizumab, another option for patients who can't tolerate standard treatments. Natalizumab, a drug with a similar mechanism of action, may increase the risk for progressive multifocal leukoencephalopathy, a brain infection. The FDA hasn't found an increased PML risk with vedolizumab, but patients should be monitored for concerning neurologic signs or symptoms.