Bristol-Myers Squibb Co. (BMY) said on Saturday that the U.S. Food and Drug Administration, or FDA, has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.
While no new clinical studies have been requested, the complete response letter requests the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The company would work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the Phase 3 studies.
Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy.
In September 2009, the Biologics License Application for belatacept was accepted for filing and review by the FDA. An FDA Advisory Committee panel met on March 1 of this year and voted 13-5 to recommend the approval of belatacept for the prophylaxis of rejection in kidney transplant recipients. The FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications.
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