🧪FDA Issues Priority Review Voucher for Gomekli Product
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib)
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 GOMEKLI (mirdametinib), approved on February 11, 2025, manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The issuance of a priority review voucher under the FD&C Act supports sponsors like SpringWorks Therapeutics, offering financial incentives for rare pediatric disease innovations, which can lead to increased investment and research opportunities.