FDA committee recommends kidney transplant drug be approved

PRINCETON, N.J. The Food and Drug Administration has recommended approval for a biotech drug for treating kidney transplant patients.

Bristol-Myers Squibb Co. announced Tuesday that the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-to-5 to recommend approval for belatacept, for preventing rejection of transplanted kidneys. Bristol submitted its application in September 2009 and expects a final decision in May.

The FDA takes committees’ recommendations into account when deciding whether or not to approve a drug, but is not bound by them.

“Bristol-Myers Squibb is encouraged by the committee’s recommendation,” Bristol SVP global development and medical affairs Brian Daniels said. “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.”

Login or Register to post a comment.