The FDA awards a second round of Commissioner’s National Priority vouchers to six larger biopharma companies. And this time, with the exception of Eli Lilly’s orforglipron, the vouchers are for drugs that are already on the market.
The FDA announced the second batch of recipients of its new Commissioner’s National Priority vouchers Thursday, and the beneficiaries strike a different tone than those awarded in the first round.
These vouchers, first introduced in June, are intended for programs that are “aligned with U.S. national priorities,” under a number of different categories, including addressing a public health crisis in the country, addressing unmet needs, onshoring drug development or increasing affordability. With a CNPV voucher, the drug review process could be shortened from 10–12 months to 1–2 months.
The products receiving vouchers in this round are:
- Novo Nordisk’s Wegovy for obesity and related health conditions. Wegovy, or semaglutide, was first approved in 2021.
- Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease. Casgevy was approved for sickle cell disease in December 2023.
- Eli Lilly’s orforglipron for treating obesity and related health conditions. Orforglipron is the only drug on this list not already approved.
- Boehringer Ingelheim’s zongertinib, for HER2 lung cancer. Zongertinib was approved as Hernexeos for non-small cell lung cancer in August.
- Johnson and Johnson’s bedaquiline for drug-resistant tuberculosis in young children. J&J subsidiary Janssen sells bedaquiline as Sirturo, approved under an accelerated pathway in 2012 before winning full FDA approval in 2024 for treating tuberculosis.
- GSK’s dostarlimab for rectal cancer. Dostarlimab is sold as Jemperli and was approved in 2023 for endometrial cancer.
The first round of CNPV recipients was announced on October 17. The nine recipients from that round represented a range of large and small pharmas and a variety of stages along the drug development pipeline. This new group, on the other hand, focuses on larger companies and drugs that are largely already approved for at least one indication.
“National priority vouchers are granted to a select group of products,” FDA Commissioner Marty Makary said in a statement Thursday afternoon, “where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need.” Priority voucher holders will receive decisions “within months” of submitting a complete application, according to the announcement, though the FDA could extend the timeline for review as needed.
Why vouchers were awarded to drugs that are already approved for the indications listed—like Wegovy for obesity, Sirturo for tuberculosis or Casgevy for sickle cell disease—was not made clear in the FDA’s announcement. BioSpace has reached out to the agency for clarification and will update this article accordingly.
“The first nine vouchers embodied a new definition of ‘unmet medical need,’ one not tied to the traditional standard of serious and life-threatening diseases,” Steven Grossman, policy and regulatory consultant, and author of the FDA Matters blog, told BioSpace in an email. Grossman pointed to vouchers for investigational drugs addressing deafness, blindness, infertility and onshoring to reduce ongoing drug shortages.
“So far, we have less information about the new set and their intended use. Hopefully, they will meet the criteria I applied to the first batch: they address unmet medical needs that are legitimately on FDA’s priority list and can be justified without reference to separate dialogues about pricing and other national (but not necessarily FDA) priorities.”
Executives from Novo Nordisk and Eli Lilly were at the White House shortly before the vouchers were announced, discussing an agreement made by both companies with the Trump administration to sell their GLP-1 medicines—semaglutide (including Wegovy) and tirzepatide, respectively—at around $350 per month through the administration’s direct-to-consumer platform TrumpRx.
