FDA Advisory Committee backs Bristol-Myers Squibb's belatacept for prophylaxis of acute rejection in kidney transplant patients; firm names new CEO

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted 13 to five to recommend approval of US drug major Bristol-Myers Squibb's belatacept, a selective co-stimulation blocker, for the prophylaxis of acute rejection in de novo kidney transplant patients. However, nearly all the members of the panel agreed that follow-up studies should be conducted by Bristol-Myers to evaluate the long-term safety of the drug candidate.

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,' said Brian Daniels, senior vice president, global development and medical affairs at B-MS.