Provention's second shot at FDA approval for diabetes prevention drug hits new hurdle
The long trek toward FDA approval for teplizumab is still getting longer.
Provention Bio said the agency is delaying a decision on its drug, which is designed to stave off type 1 diabetes, by another four months, moving the PDUFA date from August to mid-November.
This is the biotech’s second BLA after the regulators hit its first attempt at approval with a complete response letter. But the story for teplizumab goes back more than three decades, starting in the lab of former UCSF scientist Jeffrey Bluestone and passing through MacroGenics and Eli Lilly — where it was put on life support after failing a pivotal trial — before landing at Provention, with some support from Bluestone.
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