US Priority Review for Takeda's vedolizumab for ulcerative colitis

Japan’s largest drugmaker, Takeda Pharmaceutical (TYO: 4502) says that the US Food and Drug Administration (FDA) has granted Priority Review status for its US subsidiary’s Biologics License Application (BLA) for its new investigational drug vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis.

A BLA was submitted in June seeking approval for vedolizumab for the treatment of adults with moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC; The Pharma Letter June 21). The application submitted for vedolizumab for the treatment of adults with moderately to severely active CD will be reviewed by the FDA under the standard review timeline.

“Additional treatment options are needed for ulcerative colitis, and the acceptance for Priority Review of vedolizumab underscores this need,” said Karen Lasch, medical director - GI, Medical Affairs, US Region, Takeda.