FDA expands the National Priority Voucher program to oral GLP-1s

The FDA announced yesterday the second wave of National Priority Voucher recipients, including GLP-1 drug competitors Eli Lilly and Novo Nordisk, bringing the total number of products under the program to 15.

Oral GLP-1 medications Orforglipron, Lilly's investigational obesity pill, and Wegovy, Novo's tablet version of its blockbuster injectable drug, are among the selected products.

The FDA is reviewing Novo's oral Wegovy, with a decision expected by the end of the year, as Lilly prepares to file for approval of its oral obesity drug in the coming month.

As part of a broader initiative to enhance the affordability and accessibility of medications, the Trump administration also unveiled agreements with Eli Lilly and Novo Nordisk aimed at reducing prices for popular weight loss drugs.

Other National Priority Voucher recipients include Vertex's gene-editing therapy for sickle cell disease, Casgevy; GSK's anti-cancer monoclonal antibody, dostarlimab; Johnson & Johnson's pediatric antibiotic for treating drug-resistant tuberculosis, bedaquiline; and Boehringer Ingelheim's HER2-positive lung cancer treatment, zongertinib.

Launched by FDA Commissioner Marty Markary, M.D., in June, the National Priority Voucher pilot program is intended to expedite the review process for drug and biological product applications, reducing wait times from 10-12 months to 1-2 months.

"National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need," Makary said in the FDA press release. "We are pioneering new ways of bringing these cures and meaningful treatments to the market faster."

Announced less than a month ago, the first wave of voucher winners included the following nine products: Pergoveris, EMD Serono's fertility medication; teplizumab (TZIELD), Sanofi's type 1 diabetes drug; cytisinicline, Achieve Life Sciences' nicotine cessation pill; DB-OTO, Regeneron's experimental gene therapy for hearing loss; cenegermin-bkbj (Oxervate), Dompé's treatment for blindness; RMC-6236, an investigational pancreatic cancer drug from Revolution Medicine; bitopertin, a treatment for rare blood diseases; Augmentin XR, an extended-release antibiotic; and ketamine, a widely used general anesthetic.

The vouchers are non-transferable but will remain valid if a company is acquired or changes ownership. They can be assigned to a specific investigational drug or left undesignated for later use on any novel therapy the company chooses, the agency says.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.