🍀FDA Issues Priority Review Voucher for Rare Pediatric Drug
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone)
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 MODESYO (dordaviprone), approved August 6, 2025, manufactured by Chimerix, Inc., meets the criteria for a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice involves the issuance of a priority review voucher under the FD&C Act for a product treating rare pediatric diseases. This can provide financial incentives for the sponsoring company, Chimerix, Inc., promoting investment in rare disease treatments, impacting business strategies for drug developers focusing on pediatric markets.