90 FR 9 pg. 3880 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)
Type: NOTICEVolume: 90Number: 9Page: 3880
Page: 3880Docket number: [Docket No. FDA-2020-N-0026]
FR document: [FR Doc. 2025-00750 Filed 1-14-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
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.
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]
BILLING CODE 4164-01-P