The US Food and Drug Administration (FDA) announced the first recipients of its Commissioner’s National Priority Voucher (CNPV) pilot program, which is designed to expedite the review of drugs that address pressing national priorities.
The initiative aims to decide on applications within one to two months, compared with the usual accelerated approval timeline of about six months and the standard review period of roughly 10 months.
The nine drugs selected under the program target conditions, including vaping addiction, hearing loss, infertility, and pancreatic cancer.
President Donald Trump noted the potential impact of the program during a news conference on Friday, stating that the infertility product Pergoveris “would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly.”
FDA Commissioner Dr Marty Makary highlighted the agency’s goal of accelerating access to critical therapies.
“One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities,” he said in a statement.
Products selected
- Pergoveris, an injectable infertility medication produced by Merck KGaA and marketed in the US by EMD Serono, is intended to expand access to in-vitro fertilization treatments and provide a lower-cost alternative to existing options.
- Teplizumab, developed by Provention Bio and now part of Sanofi, targets Type I diabetes.
- Cytisinicline, created by Nicotera Therapeutics, is being developed as a treatment for nicotine addiction, including vaping.
- DB-OTO, developed by Decibel Therapeutics, is designed to treat hearing loss.
- Cenegermin-bkbj, marketed under the brand name Oxervate by Dompe Farmaceutici, is intended to treat certain forms of blindness.
- RMC-6236, from Revolution Medicines, is an experimental therapy for pancreatic cancer.
- Bitopertin, developed by Roche, is being studied for the treatment of porphyria, a rare metabolic disorder.
The program also includes initiatives to expand domestic manufacturing capacity for critical drugs. Multiple manufacturers, including Janssen Pharmaceuticals, are participating in an effort to increase US production of ketamine, a widely used anesthetic that has also gained attention for its use in psychiatric treatments.
Similarly, Augmentin XR, produced by several generic manufacturers including GlaxoSmithKline, has been selected to support domestic antibiotic production.