The Commissioner’s National Priority Voucher awards companies that align with specific national priorities—such as boosting domestic manufacturing and lowering drug prices—with faster reviews and more frequent interactions with the FDA.
The FDA has named the first batch of awardees for its inaugural run of the Commissioner’s National Priority Voucher program, naming nine assets that will benefit from a much shorter review period and greater regulatory guidance.
They are:
– Merck KGaA’s Pergoveris for infertility
– Sanofi’s Tzield for type 1 diabetes
– Achieve Life Sciences’ Cytisinicline for nicotine vaping addiction
– Regeneron’s DB-OTO for congenital deafness
– Dompé’s Oxervate for blindness
– Revolution Medicines’ RMC-6236 for pancreatic cancer
– Disc Medicine’s bitopertin for porphyria
– Ketamine for domestic manufacture of a general anesthetic
– GSK’s Augmentin XR for the domestic manufacturing of a common antibiotic
Writing to investors on Thursday, analysts at BMO Capital Markets said that for Disc, being awarded the commissioner’s voucher is a “strong positive” that reinforces the firm’s view that Disc is a “Biotech top pick.” Disc shares jumped 17% in after-hours trading following the FDA’s announcement.
In late September, Disc submitted a New Drug Application for bitopertin, proposing the drug as a treatment for erythropoietic protoporphyria in patients 12 years and older. According to BMO, the priority voucher award “meaningfully” expedites the review and makes “a potential approval by YE25 significantly more likely.”
Another voucher awardee is DB-OTO, Regeneron’s gene therapy for a genetic form of deafness. On Sunday, the pharma released Phase I/II data, touting that 11 of 12 treated patients demonstrated “clinically meaningful” hearing improvements, which became apparent “within weeks” of dosing. Regeneron plans an FDA filing by the end of the year.
In choosing these grantees, the FDA said it looked for products that addressed a “major national priority,” such as meeting an unmet medical need, boosting domestic manufacturing or lowering drug prices in accordance with President Donald Trump’s Most Favored Nation pricing scheme. To facilitate the selection process, each drug review unit under the FDA was asked to nominate a product that its members thought meets these goals. Companies were also allowed to apply for the program, with their proposal assessed by the corresponding drug review division.
In return for aligning with the government on these national priorities, companies with the commissioner’s priority voucher will see their review times drop from the usual 10–12 months to 1–2 months, the FDA said. The ticket will also give sponsors more frequent interactions with the agency before their final submission and during the review period.
The FDA said that it will reveal another group of voucher awardees “in the coming months.”