💊FDA Approves AMVUTTRA Under Priority Review Voucher
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AMVUTTRA (vutrisiran)
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-06) for AMVUTTRA (vutrisiran), 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
$$ - Med
The notice announces the approval of AMVUTTRA (vutrisiran) under a priority review voucher, which may incentivize other drug developers to pursue similar applications, affecting competitive dynamics in the pharmaceutical market. Compliance with FDA regulations is essential for businesses in this sector.