CreatripTeam

The U.S. Food and Drug Administration (FDA) has named nine drugs as the first recipients of its Country National Priority Voucher (CNPV) pilot program, which shortens review times from the usual 10–12 months to 1–2 months for medicines that meet U.S. national priorities while keeping safety, efficacy and quality standards. The selected products include infertility drug Pergovaris, type 1 diabetes therapy Teplizumab, nicotine vaping addiction treatment Citicineclin, gene therapy DB-OTO for hereditary hearing loss, sight-restoring Senegermin, pancreatic cancer candidate RMC-6236, porphyria drug Vitopertin, ketamine for U.S. manufacture (anesthesia), and Augmentin XR for U.S. manufacture (antibiotic). Some picks are investigational (e.g., DB-OTO) and others are existing drugs with expanded indications. Developers like Regeneron plan near-term FDA submissions, meaning some drugs could reach market as early as next year if the program proceeds as intended. The program also appears to allow top-down nominations in addition to sponsor applications, expanding initial expectations of five recipients to nine.