FDA issues complete response letter to Bristol-Myers Squibb

PRINCETON, N.J. The Food and Drug Administration has declined to approve a biotech drug for organ transplant patients made by Bristol-Myers Squibb, Bristol said Saturday.

The FDA issued a complete response letter for Bristol’s September 2009 regulatory approval application for belatacept, designed to prevent rejection of transplanted kidneys. The agency issues a complete response letter when it has finished reviewing an application, but questions remain that preclude final approval.  Specifically, the letter requested from Bristol three-year data from a late-stage clinical trial to further evaluate the drug’s long-term effect.

“Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients,” Bristol SVP global development and medical affairs Brian Daniels said. “We will continue to work closely with the FDA to address their questions.”