FDA pushes back target date for review of Takeda drug in patients with ulcerative colitis

Agency's PDUFA action date for vedolizumab in Crohn's disease remains unchanged

DEERFIELD, Ill. — The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.

Takeda said the FDA had extended the Prescription Drug User Fee Act priority review action date for vedolizumab as a treatment for UC until May 20, 2014, essentially meaning the date has been pushed back. The FDA's action date for the drug as a treatment for Crohn's disease, June 18, 2014, remains unchanged. Takeda said the delay would give the agency enough time for a full review of the application.

"This short delay in the action date allows the FDA sufficient time to complete review of the vedolizumab file and provide action on the application," Takeda head of global regulatory affairs Tom Harris said. "We appreciate the work of the FDA and remain confident in the potential of vedolizumab as an additional, important treatment option for patients with the physicians who treat them for these serious conditions."


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