The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, ...
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award of the priority review voucher. FDA has determined that ATEBRIOZ (zilurgisertib), approved September 25, 2026, manufactured by Incyte Corporation meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Scott Winiecki, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-771-1519,
Scott.Winiecki@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined ATEBRIOZ (zilurgisertib), manufactured by Incyte Corporation meets the criteria for a priority review voucher.
( printed page 67840)
ATEBRIOZ (zilurgisertib) tablets for oral use is indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).
21 U.S.C. 360ff
www.fda.gov/ForIndustry/DevelopingProductsforRareDiseaseConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm
www.accessdata.fda.gov/scripts/cder/daf/