Bristol-Myers Squibb Company announced that the US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted 13 to five 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 US 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 US 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 US 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 US 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 US FDA in September 2009 and the Prescription Drug User Fee Act goal date for US 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.