Priority Review Voucher Issuance for YUVIWEL Rare Pediatric Disease Product

Notice

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)

A Notice by the Food and Drug Administration on 04/01/2026

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• Public Inspection Published Document: 2026-06316 (91 FR 16204) Document Headings ###### Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2026-N-3004]

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 YUVIWEL (navepegritide), approved February 27, 2026, manufactured by Ascendis Pharma Growth Disorders (A/S), 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, Quyen.Tran1@fda.hhs.gov.

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 YUVIWEL (navepegritide), manufactured by Ascendis Pharma Growth Disorders (A/S), meets the criteria for a priority review voucher. YUVIWEL (navepegritide) injection is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

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 YUVIWEL (navepegritide), go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/​scripts/​cder/​daf/.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-06316 Filed 3-31-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-06316 (91 FR 16204)