FDA awards first national priority vouchers to nine drug sponsors
The U.S. Food and Drug Administration has awarded the first Commissioner’s National Priority Vouchers (CNPV) to nine sponsors, the agency said. The vouchers are intended to accelerate review of drugs and biologics with potential to address large unmet medical needs, public health crises, reduce downstream health care utilization, support domestic manufacturing, or improve affordability through “Most Favored Nation” pricing, according to the announcement.
Recipients will receive decisions within one to two months of filing a complete application and will have enhanced communications with FDA review staff throughout the development and review process, the agency said. FDA scientists may extend review timelines if an application is incomplete or manufacturing violations are identified.
Products selected for the CNPV pilot include Pergoveris for infertility, Teplizumab for Type 1 diabetes, Cytisinicline for nicotine vaping addiction, DB-OTO for deafness, Cenegermin-bkbj for blindness, RMC-6236 for pancreatic cancer, Bitopertin for porphyria, and ketamine and Augmentin XR for domestic manufacturing.
Phlow Corp., a Richmond, Virginia-based pharmaceutical contract development and manufacturing organization (CDMO), is among the recipients for its ketamine project, the company said. The project aims to establish a fully domestic supply chain for the active pharmaceutical ingredient for ketamine, addressing a multi-year shortage and reducing reliance on overseas sources, according to the announcement.
“Phlow is advancing domestic production of the active pharmaceutical ingredient for ketamine to strengthen U.S. supply chain resilience,” Phlow CEO Eric Edwards said in a statement.
The FDA plans to announce additional CNPV recipients in the coming months.