Issuance of Priority Review Voucher; Rare Pediatric Disease Product; AVLAYAH (tividenofusp alfa-eknm)
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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 AVLAYAH (tividenofusp alfa-eknm), approved March 24, 2026, manufactured by Denali Therapeutics Inc., meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 91 Issue 90 (Monday, May 11, 2026)</title>
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[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Page 25582]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09242]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4573]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product; AVLAYAH (tividenofusp alfa-eknm)
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 AVLAYAH (tividenofusp alfa-eknm), approved March 24, 2026,
manufactured by Denali Therapeutics 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.,
Bldg. 22, Room 5324, Silver Spring, MD 20993-0002, 301-796-2771,
<a href="/cdn-cgi/l/email-protection#fcad89859992d2a88e9d92cdbc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="e8b99d918d86c6bc9a8986d9a88e8c89c680809bc68f879e">[email protected]</span></a>.
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 AVLAYAH (tividenofusp alfa-eknm), manufactured by
Denali Therapeutics Inc., meets the criteria for a priority review
voucher. AVLAYAH (tividenofusp alfa-eknm) injection is indicated for
the treatment of neurologic manifestations of Hunter syndrome
(Mucopolysaccharidosis type II, MPS II) when initiated in
presymptomatic or symptomatic pediatric patients weighing at least 5 kg
prior to advanced neurologic impairment.
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 AVLAYAH (tividenofusp alfa-eknm), 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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09242 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P
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