US FDA delays approval of Bristol-Myers Squibb's belatacept for kidney transplant patients

The US Food and Drug Administration has issued a complete response letter regarding Bristol-Myers Squibb's Biologics License Application for belatacept in kidney transplantation, the drug major revealed over the weekend.

While no new clinical studies have been requested, the FDA letter requests the 36-month data from the ongoing Phase III studies to further evaluate the long-term effect of belatacept. The company said it will work with the FDA to provide the data as soon as they are available, noting that the BLA submitted for belatacept included 24-month data from the Phase III 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 (REMS), according to the drugmaker.