"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.
Belatacept is an investigational agent under development by Bristol-Myers Squibb to prevent graft rejection and maintain kidney function following renal transplantation. Belatacept is being studied to assess its efficacy and safety as an immunosuppressant agent in solid organ transplantation.
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 naÃ¯ve T-cells, which coordinate immune-mediated rejection of transplanted organs.
About Bristol-Myers Squibb
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