[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Page 3880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0026]


Issuance of Priority Review Voucher; Rare Pediatric Disease 
Product; ALHEMO (concizumab-mtci)

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 ALHEMO (concizumab-mtci), approved on December 20, 2024, 
manufactured by Novo Nordisk, Inc., meets the criteria for a priority 
review voucher.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394.

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 that ALHEMO (concizumab-mtci), manufactured by Novo 
Nordisk, Inc., meets the criteria for a priority review voucher. ALHEMO 
(concizumab-mtci) injection is indicated for routine prophylaxis to 
prevent or reduce the frequency of bleeding episodes in adult and 
pediatric patients 12 years of age and older with hemophilia A 
(congenital factor VIII deficiency) with FVIII inhibitors and 
hemophilia B (congenital factor IX deficiency) with FIX inhibitors.
    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 ALHEMO (concizumab-mtci), go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-00750 Filed 1-14-25; 8:45 am]
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