# Federal Register #2026-21910

FDA priority review voucher notice for Incyte’s ATEBRIOZ

**Buyer:** Department of Health and Human Services / Food and Drug Administration
**Posted:** October 28, 2026
**Identifier:** 2026-21910

The FDA issued a rare pediatric disease priority review voucher related to Incyte Corporation’s ATEBRIOZ (zilurgisertib) product application.
- **Government buyer/agency:** U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
- **Notice type:** Award notice; this is not a procurement solicitation.
- **OEM:** **Incyte Corporation** manufactures ATEBRIOZ (zilurgisertib) tablets.
- **Product context:** ATEBRIOZ is indicated to reduce the volume of total new heterotopic ossification in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva.
- **Purchase requirements:** No products or services are requested, and no quantities, part numbers, or contract requirements are specified.

### Description

The FDA announces issuance of a priority review voucher to the sponsor of the rare pediatric disease product application for ATEBRIOZ (zilurgisertib), manufactured by Incyte Corporation. FDA states the product was approved on September 25, 2026, and meets the criteria for a priority review voucher. ATEBRIOZ tablets are indicated to reduce the volume of total new heterotopic ossification in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva.

[View original listing](https://www.federalregister.gov/documents/2026/10/28/2026-21910/issuance-of-priority-review-voucher-rare-pediatric-disease-product-atebrioz-zilurgisertib)