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.
"This short delay in the action date allows the FDA sufficient time to complete the review of the vedolizumab file and provide action on the application," said Tom Harris, head, global regulatory affairs, Takeda. "We appreciate the work of the FDA and remain confident in the potential of vedolizumab as an additional important treatment option for patients and the physicians who treat them for these serious conditions."
On December 9th, a joint panel of members from the Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees of the FDA voted to recommend approval of Takeda's vedolizumab for both proposed UC and CD indications. The outcome of the advisory committee meeting is non-binding and will be taken into consideration by the FDA when making its decision on Takeda's BLAs for vedolizumab.
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