Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KYGEVVI (Doxecitine and Doxribtimine)
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 13 (Wednesday, January 21, 2026)</title>
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[Federal Register Volume 91, Number 13 (Wednesday, January 21, 2026)]
[Notices]
[Pages 2536-2537]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01065]
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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.
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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
[[Page 2537]]
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 <a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm">https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm</a>. For further
information about KYGEVVI (doxecitine and doxribtimine), go to the
``Drugs@FDA'' website at <a href="https://www.accessdata.fda.gov/scripts/cder/daf/">https://www.accessdata.fda.gov/scripts/cder/daf/</a>.
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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