When Muscles Turn to Bone, FDA Grants a Rare-Drug Voucher
Published Date: 10/28/2026
Notice
Summary
The FDA just gave Incyte Corporation a special priority review voucher for their rare pediatric disease drug, ATEBRIOZ (zilurgisertib), approved on September 25, 2026. This drug helps kids and adults with a rare condition called fibrodysplasia ossificans progressiva (FOP). The voucher speeds up future FDA reviews, saving time and potentially money for Incyte and encouraging more rare disease treatments.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA approval of ATEBRIOZ for FOP
ATEBRIOZ (zilurgisertib) was approved on September 25, 2026 for use in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The label says it is indicated to reduce the volume of total new heterotopic ossification (HO) in these patients.
Priority review voucher issued to Incyte
The FDA issued a Priority Review Voucher to the sponsor, Incyte Corporation, for ATEBRIOZ under section 529 of the Federal Food, Drug, and Cosmetic Act. The notice states the product met the statutory criteria and the voucher award is being published.
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