FDA Hands Out Million-Dollar Fast-Pass for Drug Approvals
Published Date: 1/10/2025
Notice
Summary
The FDA just gave a special priority review voucher to Neurocrine Biosciences for their rare pediatric disease drug, CRENESSITY (crinecerfont), approved in December 2024. This voucher speeds up future drug reviews, helping get important medicines to kids faster. It’s a big win for patients with rare diseases and could save time and money in drug development.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Approves CRENESSITY for CAH
CRENESSITY (crinecerfont) was approved on December 13, 2024 as an FDA-approved treatment for glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia. If you or a child you care for has this condition, there is now an FDA‑approved medicine with that indication.
Priority Review Voucher Issued to Sponsor
The FDA issued a Rare Pediatric Disease Priority Review Voucher to Neurocrine Biosciences for CRENESSITY (crinecerfont) under section 529 of the FD&C Act. The notice states the voucher was awarded following the drug's approval on December 13, 2024 and that FDA is publishing the award.
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