Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)
Published Date: 1/10/2025
Notice
Summary
The FDA just gave the green light to ALYFTREK, a new medicine for rare childhood diseases, using a special priority review voucher that speeds up approval. This means kids with rare conditions can get access to this treatment faster, and drug makers get rewarded for developing these important medicines. The approval happened on December 20, 2024, marking a big win for patients and innovators alike!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Approval of ALYFTREK
The FDA approved ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) tablets on December 20, 2024 as a rare pediatric disease product under the Rare Pediatric Disease Priority Review Voucher program. If you are a parent or guardian of a child for whom ALYFTREK is indicated, this approval is the official FDA authorization of that product.
Voucher Awarding to Drug Sponsors
Under section 529 of the Federal Food, Drug, and Cosmetic Act, FDA awards Rare Pediatric Disease Priority Review Vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. The notice confirms that a voucher was redeemed in the approval of ALYFTREK.
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