The eRulemaking Program
01/21/2026 | Press release | Distributed by Public on 01/21/2026 07:01
Priority Review Voucher: Rare Pediatric Disease Product; Kygevvi (Doxecitine and Doxribtimine)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-7129]
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine)
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
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 KYGEVVI (doxecitine and doxribtimine), approved November 3, 2025, manufactured by UCB, Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Quyen Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2771.
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 KYGEVVI (doxecitine and doxribtimine), manufactured by UCB, Inc., meets the criteria for a priority review voucher. KYGEVVI (doxecitine and doxribtimine) powder is indicated for treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.
For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about KYGEVVI (doxecitine and doxribtimine), go to the "Drugs@FDA" website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Lowell Zeta,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-01065 Filed 1-20-26; 8:45 am]
BILLING CODE 4164-01-P
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