Bristol-Myers Squibb is going to have to wait a while longer before it knows whether the FDA will allow it to market belatacept to help prevent patients' immune systems from rejecting new kidney transplants. Regulators said that they want to look over 36-month follow-up data from the Phase III study. The company had submitted 24-month data with its biologics application.
Regulators also want more info on "the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy." Significantly, the FDA did not ask for any new studies. The delay may come as a bit of a surprise for BMS, which won a 13-5 expert panel vote in favor of recommendation.
Belatacept is a fusion protein designed to be a selective T cell co-stimulation blocker that binds to a specific site on certain cells of the immune system to block the second signal necessary to activate T cells, which play a big role in transplant rejection. BMS shares were down slightly this morning.
- check out BMS' press release
- here's the story from Dow Jones (sub. req.)