An FDA advisory panel has voted to back Bristol-Myers Squibb's belatacept, a new therapy designed to prevent the rejection of new kidney transplants. The experts voted 13 to 5 in favor of recommending an approval of the therapy, making it an odds-on favorite for an official approval by the FDA.
It wasn't all clear sailing for the company, though. FDA staffers had red flagged concerns about serious side effects, highlighting a type of lymphoma and one case of progressive multifocal leukoencephalopathy, or PML. But staffers had also spotlighted data demonstrating that patients taking the drug had better outcomes with better functioning organs two years after their transplant procedures.
BMS had countered that lower doses of the drug would likely resolve any issues with side effects. The PDUFA date on the drug is May 1.
- check out the BMS release
- here's the story from the Wall Street Journal