Belatacept is an investigational agent under development by Bristol-Myers Squibb for the prophylaxis of organ rejection in adult patients receiving kidney transplants.
The complete response letter requests the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of Belatacept.
Bristol-Myers Squibb is expected to 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.
Additionally, other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy.
Reportedly, the biologics license application for Belatacept was accepted for filing and review by the FDA in September 2009. 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.
FDA said that it is not bound by the recommendations of its advisory committee, but takes its advice into consideration when reviewing new drug applications.
Brian Daniels, senior vice president of global development and medical affairs at Bristol-Myers Squibb, said: "Bristol-Myers Squibb is committed to Belatacept as a potential new therapeutic option for kidney transplant patients. We will continue to work closely with the FDA to address their questions."