Peptide News Digest

#National-Priority-Voucher

2 stories

Regulatory · View digest

FDA Awards Three National Priority Review Vouchers to Psychedelic Drug Developers — Same Program That Accelerated Foundayo

On April 24 the FDA awarded three National Priority Review Vouchers to companies developing psychedelic therapies: Compass Pathways (psilocybin for treatment-resistant depression), Otsuka Pharmaceutical, and the non-profit Usona Institute (methylone for PTSD). This is the same voucher program that enabled Lilly's Foundayo (orforglipron) to be reviewed in 50 days. The program's expansion into psychedelics signals FDA's continued willingness to use priority vouchers aggressively for novel mental health and metabolic candidates — with peptide developers watching closely ahead of the July PCAC meeting.

Regulatory · View digest

FDA Approves Regeneron's Otarmeni Gene Therapy for Inherited Hearing Loss — First Gene Therapy Under National Priority Voucher

The FDA granted accelerated approval April 23 for Regeneron's Otarmeni (lunsotogene parvec-cwha), a gene therapy for certain forms of genetic hearing loss. Otarmeni is the first gene therapy cleared under the FDA's National Priority Voucher program and will be offered to eligible patients at no cost. The approval validates the priority voucher pathway's applicability beyond GLP-1 drugs and establishes regulatory precedent that peptide developers may invoke if the July PCAC meeting produces favorable reclassification recommendations.