FDA adds 6 more drugs to pilot program to expedite drug reviews in national interest
Two obesity drugs are among six new drugs that could get faster FDA review under a new pilot program opening up products targeting certain national health priorities.
Rare diseases, infectious diseases and cancer are other treatment areas covered by the new batch of voucher recipients. Thursday's announcement of the coupons comes three weeks after the FDA unveiled the first nine drugs for the commissioner's National Priority Voucher (CNPV) program. Eligible products must meet criteria such as improving affordability or increasing domestic manufacturing. Another consideration is addressing unmet public health needs.
The obesity drugs receiving coupons are Novo Nordisk's injectable GLP-1 drug Wegovy and Eli Lilly and Company's oral GLP-1 drug orforglipron. While Wegovy is approved for obesity, Novo is studying the drug in related indications. In August, Wegovy expanded its approval to include fatty liver disease MASH. Eli Lilly's orforglipron is not yet approved but could provide patients with a more convenient oral alternative to GLP-1 injections. In Eli Lilly's third quarter 2025 financial results report, the company stated that it plans to submit an application for orforglipron to the FDA before the end of this year.
Two cancer drugs are getting coupons. The first is Boehringer Ingelheim’s zongertinib, brand name Hernexeos. In August, the FDA granted accelerated approval to Hernexeos as a second-line treatment for advanced non-small cell lung cancer that expresses the cancer protein HER2. Phase 3 testing is evaluating Boehringer Ingelheim's pill as a first-line treatment alongside Merck's checkpoint inhibitor Keytruda. Preliminary data are expected to be released late next year.
GlaxoSmithKline's checkpoint inhibitor dostarlimab (brand name Jemperli) is another cancer drug getting coupons. Jemperli was initially approved in 2021 to treat endometrial cancer with the dMMR gene signature and has since expanded its approved use to all solid tumors with this signature. The coupon covers the product's potential use in rectal cancer, where it could provide a pharmaceutical alternative to surgery.
Vertex Pharmaceuticals received a coupon for Casgevy. The FDA approved the gene therapy in 2023 to cover sickle cell disease patients ages 12 and older. A clinical trial is underway that could support expanding use of the product to patients ages 5 to 11 years.
Johnson & Johnson's antibiotic bedaquiline (trade name Sirturo), a drug that treats tuberculosis in adults and children ages 5 and older, ranked last. Last year, the FDA converted the drug's accelerated approval to traditional approval. This coupon covers the use of Sirturo in drug-resistant tuberculosis in young children.
Products awarded vouchers are selected from external company applications and internal nominations from FDA's 27 review divisions across therapeutic areas. While a standard drug review can take ten months to a year, the FDA said National Vouchers could lead to a regulatory decision “within months.” Faster decisions will come from a day-long team review that brings together select physicians and scientists from multiple disciplines across the agency.
Commissioner Marty Makary announced the new priority review bonding program in June. The FDA noted that the agency has the authority to test innovative regulatory approaches under three federal laws: the Food, Drug, and Cosmetic Act; the 21st Century Cures Act; and the Food and Drug Administration Safety and Innovation Act.
“We are pioneering new ways to bring these treatments and meaningful treatments to market faster,” Makari said in a prepared statement.
Photo courtesy of FDA
