Industry Watch Alert
Key Takeaways
- The FDA awarded nine National Priority Vouchers to sponsors advancing treatments and manufacturing initiatives in critical public health areas.
- The National Priority Voucher Program provides priority review incentives for qualifying innovations.
- Applicants will be notified of a decision within one to two months after submitting a complete drug or biologic application.
- Several awards recognize domestic manufacturing projects, reflecting the FDA’s ongoing focus on supply chain resilience and public health preparedness.
Impact
- Marks the first operational rollout of the FDA’s National Priority Voucher initiative.
- Encourages innovation in high-impact therapeutic and manufacturing areas.
- Provides priority review incentives that could shorten regulatory timelines for critical therapies.
- Establishes a precedent for future voucher distribution.
Products and Sponsors Recognized
The FDA awarded nine products and their sponsors under this inaugural initiative, each representing a significant contribution to public health innovation:
- Pergoveris – Developed for infertility treatment. Pergoveris combines recombinant FSH and LH to support ovarian stimulation in women with severe luteinizing hormone and follicle-stimulating hormone deficiency.
Product Information – EMD Serono - Teplizumab (Tzield) – Approved for delaying the onset of Stage 3 type 1 diabetes in at-risk individuals. The sponsor, Provention Bio (a Sanofi company), was recognized for innovation in immune modulation.
Product Page – Sanofi - Cytisinicline – A plant-derived therapy for smoking and vaping cessation, developed by Achieve Life Sciences, representing a major advance in combating nicotine dependence.
Product Information – Achieve Life Sciences - DB-OTO – A gene therapy under development by Regeneron Pharmaceuticals and Decibel Therapeutics for congenital hearing loss caused by otoferlin deficiency.
Company Overview – Regeneron
Pipeline – Decibel Therapeutics (Regeneron) - Cenegermin-bkbj (Oxervate) – A recombinant human nerve growth factor developed by Dompé for the treatment of neurotrophic keratitis, a rare degenerative eye disease.
Product Page – Dompé - RMC-6236 – A RAS(ON) inhibitor by Revolution Medicines for the treatment of pancreatic and other RAS-mutant cancers, advancing oncology precision medicine.
Pipeline – Revolution Medicines - Bitopertin – An investigational oral therapy by Disc Medicine for the treatment of erythropoietic protoporphyria, a rare genetic disorder affecting heme biosynthesis.
Pipeline – Disc Medicine - Ketamine (Domestic Manufacturing Initiative) – Recognized under the CNPV program for domestic production of this essential anesthetic, supporting the FDA’s goal of strengthening U.S. drug supply resilience.
FDA Drug Shortages Program - Augmentin XR (Amoxicillin/Clavulanate Extended Release) – Recognized for efforts in re-establishing U.S.-based manufacturing of a high-demand antibiotic, enhancing domestic antibiotic supply security.
Product Label – FDA Database
Sources
- U.S. Food and Drug Administration (FDA)
FDA Awards First-Ever National Priority Vouchers to Nine Sponsors
https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors
FAQ
Q1: What is the FDA’s National Priority Voucher (NPV) Program?
The NPV Program incentivizes the development of high-priority medical products by awarding vouchers for future priority reviews.
Q2: Who were the first recipients of the FDA’s National Priority Vouchers?
Nine sponsors were recognized for innovative products addressing infertility, diabetes, smoking cessation, congenital hearing loss, rare eye disease, oncology, porphyria, and domestic drug manufacturing.
Q3: How does a National Priority Voucher affect the FDA approval process?
Sponsors may redeem or sell the voucher to obtain priority review for a subsequent product, reducing review time from the standard 10 months to approximately 1-2 months.
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