Belatacept Biologics License Application: FDA drug advisory committee recommends approval

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration’s (FDA) 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 (IL-2) receptor antagonist, a mycophenolic acid (MPA), and corticosteroids.

“Bristol-Myers Squibb is encouraged by the Committee’s recommendation. We will continue to work closely with the FDA to support the review of belatacept, which has the potential to provide another treatment option for kidney transplant patients”

“Bristol-Myers Squibb is encouraged by the Committee’s recommendation. We will continue to work closely with the FDA to support the review of belatacept, which has the potential to provide another treatment option for kidney transplant patients,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb.

The FDA Cardiovascular and Renal Drugs Advisory Committee based its recommendation on review of data from the belatacept clinical development program, which included more than 1,000 patients who received belatacept. Data presented included safety and efficacy results from three similarly designed clinical studies in adult de novo kidney transplant patients: a Phase 2 study (IM103100) and two Phase 3 studies, one in standard criteria (living or deceased) donor kidney transplants (IM103008) and one in extended criteria donor kidney transplants (IM103027). Belatacept is being studied in other ongoing and planned clinical trials.

The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications. The Biologics License Application for belatacept was accepted for filing and review by the FDA in September 2009 and the Prescription Drug User Fee Act goal date for FDA action is May 1, 2010.