In a unanimous 21-0 vote, the panel agreed that Takeda had "adequately characterized the potential risk of PML" to support approval, but panelists recommended postmarketing follow-up for PML and other serious adverse events in treated patients.
The FDA is expected to make a decision on approval for the ulcerative colitis indication by Feb. 18, 2014, and for the Crohn’s disease indication by June 18, 2014.
The FDA usually follows the recommendations of its advisory panels. Members of FDA panels have usually been cleared of conflicts related to the product under review; occasionally, a panelist is given a waiver, but not at this meeting.
If approved, Takeda plans to market vedolizumab as Entyvio.
