The U.S. Food and Drug Administration (FDA) has selected nine drugs for expedited review under its new National Priority Voucher pilot program, designed to fast-track treatments that address major health needs.
Instead of the typical 10–12 month review, these drugs could be approved in one to two months. The FDA says the program will use team-based reviews rather than the conventional siloed approach.
Highlighted drugs include:
- Pergoveris (Merck KGaA) — fertility treatment
- Teplizumab (Sanofi) — type 1 diabetes
- DB-OTO (Regeneron) — for deafness
- Cenegermin-bkbj — for eye conditions / blindness
- Bitopertin — for porphyria (Disc Medicine)
- Augmentin XR — for antibiotic manufacturing domestically
- RMC-6236 (Revolution Medicines) — pancreatic cancer
- A drug for nicotine vaping addiction (cytisinicline)
The FDA launched this Commissioner’s National Priority Voucher pilot earlier this year to accelerate treatments that contribute to public health goals, such as meeting unmet medical needs or reducing long-term care costs.
Some companies saw immediate stock boosts after the announcement. Revolution Medicines jumped ~7.4% and Disc Medicine soared ~19% in extended trading.
Officials also noted that Eli Lilly’s experimental weight-loss drug orforglipron could be eligible in future rounds, though it was not included in this first batch.
