Bristol-Myers Squibb Announces Acceptance Of Submission For Belatacept Biologic License Application

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals;  Transplants / Organ Donations
Article Date: 04 Sep 2009 - 23:00 PDT

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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."

About Belatacept

Belatacept is an investigational agent under development by Bristol-Myers Squibb to help prevent graft rejection and maintain kidney function following renal transplantation. Belatacept is being studied to assess its efficacy and safety as a maintenance immunosuppressant agent.

Belatacept is a fusion protein designed to be a selective co-stimulation blocker that binds to a specific site on certain cells of the immune system (i.e., antigen presenting cells) to block the second signal necessary to activate naïve T-cells, which coordinate immune-mediated rejection of transplanted organs.

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Bristol-Myers Squibb