Bristol-Myers Squibb Co. (BMY) said on Monday that the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted 13 to 5 to recommend approval of belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients.
The belatacept Biologics License Application was submitted to the FDA for an indication of prophylaxis of organ rejection and preservation of a functioning allograft in adult patients receiving renal transplants with use in combination with an interleukin-2 receptor antagonist, a mycophenolic acid, and corticosteroids.
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