Takeda Pharmaceutical Company Limited ("Takeda") and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food & Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Priority Review action date for the ulcerative colitis (UC) indication of Takeda's investigational biologic, vedolizumab. At the FDA's request, Takeda submitted a major amendment to its Biologics License Application (BLA) on December 6th which included updated proposed labeling. The FDA has now assigned a PDUFA action date of May 20, 2014 to allow the Agency time for a full review of the submission for the indication of the treatment of adults with moderately to severely active UC.
Vedolizumab is also under review for the treatment of adults with moderately to severely active Crohn's disease (CD). The action date for the CD indication remains June 18, 2014. The BLA for vedolizumab was submitted in June 2013, and the FDA granted Priority Review status for the proposed indication in UC in September 2013 and standard review for the indication of CD.