Takeda's IBD drug backed by FDA panel

|About: Takeda Pharmaceutical Co., ... (TKPHF)|By:, SA News Editor

Takeda's (TKPHF +1.4%) vedolizumab had a rather easy go of it Monday, as an FDA panel voted overwhelmingly that the drug should be approved as a maintenance therapy for Crohn's disease and as a treatment for Crohn's and ulcerative colitis in patients not helped by prior therapies.

Nevertheless, the vote was far closer (12-9) regarding whether the treatment should be available as an early therapy.

"The FDA's efficacy concerns stem from some up-and-down data in vedolizumab's pivotal trials," FierceBiotech's Damien Garde notes, before adding that, on the bright side, "the panel voted 21-0-0 that the company had adequately characterized the drug's risks of PML."