The eRulemaking Program

07/17/2024 | Press release | Distributed by Public on 07/17/2024 06:46

Approval of Product under Voucher: Rare Pediatric Disease Priority Review Voucher; Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]

Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)

Agency

Food and Drug Administration, HHS.

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-5) for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024, meets the criteria for redeeming 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, email: [email protected].

Supplementary Information

FDA is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the supplemental application (Supplement-5) for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) meets the redemption criteria.

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 VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), go to the "Drugs@FDA" website at https://www.accessdata.fda.gov/scripts/cder/daf/.

Dated: July 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15695 Filed 7-16-24; 8:45 am]
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