💊FDA Approves TREMFYA Under Rare Pediatric Disease Voucher
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab)
Summary
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-24) for TREMFYA (guselkumab), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The FDA's approval of TREMFYA (guselkumab) under the Rare Pediatric Disease Priority Review Voucher Program creates a significant business opportunity for pharmaceutical companies in developing treatments for rare pediatric diseases. This regulatory approval can enhance market access and potentially increase funding opportunities.