The FDA has issued an initial batch of nine national-priority review passes, enabling organizations such as Merck KGaA, Sanofi and Regeneron to wrap up their authorization steps within about one to two months.
Agency chief Marty Makary rolled out the initiative in June, and applications opened the following month. The effort aims to shrink the usual 10- to 12-month clearance window for therapies that support key federal objectives. Those objectives cover tackling major domestic health threats, responding to significant untreated patient populations and advancing high-impact therapeutic innovations.
This opening group of Commissioner’s National Priority Voucher, or CNPV, holders comprises both authorized treatments and pipeline candidates. Among the in-development assets is DB-OTO, the auditory gene therapy Regeneron is advancing to address a rare inherited hearing disorder.
Regeneron intends to submit its application to the FDA before year-end. If the fast-track voucher functions as expected, the treatment could reach the market by early next year. The company has shared findings from 12 participants, with nine of those individuals dosed in just one ear rather than both.
In an FDA podcast, Mallika Mundkur, who oversees the CNPV program at the agency, described the DB-OTO findings as highly impressive but noted that more information is needed regarding safety. The episode was hosted by Makary, who said the evidence of hearing restoration underscores the importance of the FDA issuing a timely decision through its usual scientific review process without unnecessary delays.
Makary also commented that there are indications the company may offer the treatment either free of charge or at a very low cost, aligning with national efforts to improve drug affordability. One requirement of the CNPV pathway is that the U.S. price of a therapy be reduced in line with most-favored pricing benchmarks.
Two other voucher awardees include Revolution Medicines’ RMC-6236 and Disc Medicine’s bitopertin. RMC-6236, also referred to as daraxonrasib, is a RAS-MULTI(ON) inhibitor being tested in phase 3 studies for certain pancreatic cancers and non-small cell lung cancer. Results from one of those trials are expected sometime next year. Revolution is waiting to see how the voucher affects its strategy before making any timeline revisions.
While speaking about RMC-6236 on the podcast, Makary noted that the FDA’s cancer review team considers the therapy to have meaningful potential. He added that the agency is actively engaging its internal divisions and asking assessors which experimental products they believe could be impactful in the future. Makary portrayed these discussions as part of a shift away from the FDA solely reacting to submissions and toward more proactively spotting candidates it can help advance more quickly.
The agency also granted vouchers to Merck for pergoveris and to Sanofi for teplizumab. Pergoveris, used in fertility care, is already marketed in over 70 countries. Merck intends to use its voucher when it submits the drug for U.S. clearance, a plan the company revealed in connection with a larger federal partnership aimed at widening access to reproductive treatments. Teplizumab, marketed by Sanofi as Tzield, already has U.S. authorization to postpone the development of certain kinds of Type 1 diabetes.
Other CNPVs are given to cytisinicline and cenegermin-bkbj for nicotine vaping addiction and for blindness, respectively. The final two are geared towards onshoring.
The U.S. Food and Drug Administration (FDA) has announced the distribution of Commissioner’s Priority Vouchers to several deserving firms that have demonstrated exceptional innovation in drug and therapy development. These vouchers serve as a powerful incentive, allowing companies to expedite the review process for future drug applications — potentially reducing approval time by several months.
The FDA Commissioner’s Priority Voucher Program is designed to recognize pharmaceutical and biotechnology firms that focus on developing treatments for serious, rare, or neglected diseases. By granting these vouchers, the FDA aims to motivate continued research and investment in areas that often receive limited commercial attention.
Receiving a Priority Voucher not only accelerates regulatory review but also adds significant commercial value to a company’s portfolio, as these vouchers can be transferred or sold to other organizations. This system ensures that both large and small firms can benefit from enhanced flexibility in bringing innovative products to market.
Industry experts believe that this initiative will continue to boost pharmaceutical innovation, ultimately ensuring that patients gain faster access to life-saving drugs and therapies. The FDA’s commitment to supporting scientific progress remains central to its mission of protecting and promoting public health.
