💊FDA Issues Priority Review Voucher for Rare Pediatric Disease Product
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)
Summary
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ALHEMO (concizumab-mtci), approved on December 20, 2024, manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice indicates a priority review voucher issuance for a rare pediatric disease product, which creates potential financial opportunities and incentives for pharmaceutical companies like Novo Nordisk. This regulatory action could impact compliance requirements and business strategies in research and development for rare diseases.