Drugs

9 Vouchers Awarded Under New Priority Review Pilot

David McFarland

— 2 min read
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FDA has announced the first nine voucher recipients under the recently launched Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with “Most Favored Nation” pricing, according to an agency release. 

Under the program (see earlier story), drug developers may redeem the vouchers to participate in the agency pilot that shortens review times from about 10-12 months to 1-2 months following submission of a final drug application. An earlier FDA notice said the agency will convene experts for a team-based review rather than using the standard review system of a drug application being sent to numerous offices.

In addition to the voucher program’s one- to two-month expedited review timeline, recipients will also receive enhanced communication and guidance from review staff throughout development and review. The agency may still extend timelines if applications are incomplete or manufacturing issues arise, FDA says.

The press release quotes commissioner Marty Makary saying the new voucher model represents an effort to “modernize the review process and try new approaches to meet the needs of the American people.” He adds that the agency’s goal is to “deliver more cures and meaningful treatments — especially ones that have an outsized impact on our most pressing national priorities.”

President Donald Trump highlighted the program during an “Improving Fertility Care and Expanding Access to IVF for Americans” press conference 10/16, noting that EMD Serono’s infertility drug Pergoveris, one of the voucher recipients, will increase market competition and reduce costs. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market,” Trump said.

To compress the standard 10–12 month FDA review period, the agency says it is assembling a multidisciplinary team of physicians and scientists who will work collaboratively with sponsors throughout development. Reviews are conducted concurrently rather than sequentially, culminating in a one-day “tumor board–style” meeting to finalize decisions.

Each FDA drug review division nominated a product that met the program’s criteria, including significant public health impact, potential to reduce health care utilization, or ability to enhance domestic drug manufacturing capacity. The first nine products selected are:

  • Pergoveris (follitropin alfa / lutropin alfa) for infertility — marketed by Merck KGaA/EMD Serono
  • Teplizumab (Tzield) for Type 1 diabetes — originally developed by Provention Bio and now part of Sanofi’s development portfolio
  • Cytisinicline for nicotine vaping addiction — developed by Achieve Life Sciences
  • DB-OTO, a gene therapy for otoferlin-related hearing loss) — being advanced by Regeneron Pharmaceuticals
  • Cenegermin-bkbj (Oxervate) for blindness — developed, manufactured and marketed by Dompé
  • RMC-6236 for pancreatic cancer — developed by Revolution Medicines
  • Bitopertin for porphyria — currently in development at Disc Medicine
  • Ketamine for clinical/general-anesthesia use (domestic manufacturing) — a generic anesthetic manufactured by multiple pharmaceutical firms;
  • Augmentin XR (amoxicillin/clavulanate extended-release) for domestic manufacturing of a common antibiotic — a generic manufactured by multiple pharmaceutical firms

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