Weight-loss Drugs Lead Latest Batch of FDA Priority Voucher Recipients

The FDA awarded its second batch of 'Commissioner's National Priority Vouchers' to six companies on November 6, 2025, expediting reviews for drugs considered U.S. national priorities13478.

Weight-loss drugs were highlighted, with Novo Nordisk receiving a voucher for an oral version of Wegovy (semaglutide), and Eli Lilly for its experimental oral obesity pill orforglipron12347.

These vouchers cut FDA review times from the standard 10-12 months to just one to two months for the selected drugs234.

As part of these awards, Novo Nordisk and Lilly entered agreements to lower prices of their weight-loss drugs, particularly for Medicare and Medicaid, in exchange for receiving the expedited review vouchers from the Trump administration13.

Other voucher recipients in this batch include:
Vertex's sickle cell gene therapy Casgevy, GSK's dostarlimab for rectal cancer, Johnson & Johnson's (or Takeda's) bedaquiline for pediatric drug-resistant tuberculosis, and Boehringer Ingelheim's and BeiGene’s zongertinib for HER2-mutant lung cancer23457.

The Commissioner's National Priority Voucher program began in June 2025, bringing the total awarded to 15 as of this round3457.

Vouchers are granted to companies committed to increasing affordability, onshoring manufacturing, or addressing unmet public health needs, according to FDA Commissioner Marty Makary247.

Analysts note the commercial impact for Novo is modest, as approval for oral Wegovy was already anticipated by year-end3.

Sources:

1. https://www.statnews.com/2025/11/06/fda-priority-review-vouchers-granted-eli-lilly-novo-nordisk-vertex/

2. https://www.fiercebiotech.com/biotech/fda-announces-second-round-priority-voucher-winners-including-glp-1-leaders-lilly-and-novo

3. https://www.newsmax.com/health/health-news/fda-fast-track-vouchers-drug-reviews/2025/11/07/id/1233599/

4. https://mix929.com/2025/11/06/us-fda-awards-six-more-fast-track-vouchers-to-speed-drug-reviews/

5. https://wiky.com/2025/11/06/us-fda-awards-six-more-fast-track-vouchers-to-speed-drug-reviews/

7. https://www.933thedrive.com/2025/11/06/us-fda-awards-six-more-fast-track-vouchers-to-speed-drug-reviews/

8. https://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers

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