News briefing: 10 years later, teplizumab gets a second shot at an FDA OK; J&J files for amivantamab approval in Europe
Teplizumab’s 10-year trek back into the R&D spotlight is getting another assist from the FDA.
The agency has provided a brief priority review schedule for the type 1 diabetes drug, according to Provention Bio. And that sets up a July 2 PDUFA date for a drug that already won the agency’s breakthrough therapy status.
Teplizumab had lingered for years in limbo after Eli Lilly decided to punt on the drug following a pivotal failure in diabetes. But its scientific discoverer, longtime UCSF vet and now biotech entrepreneur Jeffrey Bluestone, never lost hope. He found new believers at Provention, who picked up rights to the drug and quickly made their way back to the FDA.
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