Filing and review of belatacept's license application accepted by the FDA

Sep 4 2009NewsGuard 100/100 Score

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the company’s submission of a biologic license application for belatacept, which is in ongoing phase III development for use in kidney transplantation.

The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is May 1, 2010.

“Belatacept has the potential to address significant unmet medical needs of transplant patients,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. “We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency.”

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