Novo Nordisk Accelerates High-Dose Wegovy Review Using FDA Priority Voucher

Novo Nordisk has taken a significant step in expanding its obesity treatment portfolio by utilizing a newly awarded FDA National Priority Voucher for an expedited review of a higher-dose formulation of its popular weight loss drug, Wegovy (semaglutide). This move comes amid growing competition in the GLP-1 receptor agonist market and increased scrutiny of the FDA's new priority review program.

Accelerated Review for 7.2 mg Wegovy

Novo Nordisk has filed for regulatory approval of a 7.2 mg dose of Wegovy, leveraging its recently acquired National Priority Voucher from the FDA. This voucher, part of the Commissioner's National Priority Voucher (CNPV) program, promises to slash the typical review time to just one to two months, potentially aligning the approval with the company's oral semaglutide decision expected in Q4 2025.

The higher dose formulation has shown promising results in clinical trials. In the Phase 3 Step Up trial, patients receiving once-weekly injections of 7.2 mg semaglutide achieved an average weight loss of 20.7% after 72 weeks, compared to 17.5% with the current 2.4 mg dose. Notably, 33.2% of patients on the higher dose reached or exceeded a 25% weight reduction, more than doubling the 16.7% seen in the 2.4 mg group.

Anna Windle, Ph.D., Novo's SVP of clinical development, medical and regulatory affairs, stated that the new formulation aims to "bring patients and healthcare professionals a new option for greater weight loss potential, further underlining the efficacy that the semaglutide molecule can bring."

Controversy Surrounding the CNPV Program

The FDA's CNPV program, launched in June 2025, has come under scrutiny from lawmakers and industry experts. The program offers an "unprecedented opportunity" for ultra-fast reviews, reflecting the FDA's commitment to modernizing regulatory frameworks. However, concerns have been raised about the program's implementation and potential implications.

New Jersey Rep. Frank Pallone Jr. and Independent Vermont Sen. Bernie Sanders have expressed "deep concerns" about the program in a letter to FDA Commissioner Marty Makary, M.D. They worry that it could "enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump."

Critics have also questioned the exclusion of regular FDA review team members from the first CNPV review, which instead featured high-ranking agency leaders. Additionally, reports suggest that even top FDA leadership, including Richard Pazdur, M.D., the new director of the Center for Drug Evaluation and Research (CDER), have raised concerns about the "legality and pace" of initiatives to speed up drug decisions.

Despite these controversies, a spokesperson for the Department of Health and Human Services (HHS) defended the program, stating that it "provides a clear incentive for investment in areas where innovation has lagged, while preserving the FDA's rigorous standards for safety and effectiveness."