FDA staffers balance risks, benefits of BMS' belatacept

With an FDA expert panel review for Bristol-Myers Squibb's belatacept coming up at the beginning of next week, agency staffers got their chance to weigh in on the therapy's pros and cons, noting that kidney transplant patients taking the drug demonstrated better survival rates, improved kidney function and lower blood pressure. The injectable biologic is designed to prevent organ rejection and maintain kidney function in patients with end-stage renal disease.

Those positive points, though, were balanced by concerns regarding a higher rate of severe kidney rejections and instances of a rare, often fatal, neurological disease called progressive multifocal leukoencephalopathy. Those risks prevent the therapy from being a "slam dunk" for BMS, notes Seamus Fernandez of Leerink Swann. And they also are likely to blunt the drug's market impact if it does make its way through the panel vote and on to an FDA approval.

"Careful consideration should be given to whether the data regarding the observed benefits associated with the belatacept regimen ... outweigh the risks of higher mortality and excess morbidity," the staff writes.

- here's the Reuters story
- and here's the AP report

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