Peter Marks, CBER director (Jim Lo Scalzo/Pool via AP Images)
FDA's Peter Marks talks reimbursement of gene therapies that win accelerated approval
LOS ANGELES — “Everyone who thinks that the drug should be approved, raise your right hand, and everyone who thinks the drug should not be approved, raise your left hand.” Keith Wonnacott, Lexeo Therapeutics’ VP of regulatory affairs, queried a full audience about whether it thought Sarepta’s gene therapy for Duchenne muscular dystrophy should be granted accelerated approval.
Many raised their right hands, a few people raised their left. Most abstained, looking around the room to survey their peers’ reactions.
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