Issuance of Priority Review Voucher; Rare Pediatric Disease Product; LOARGYS (pegzilarginase-nbln)
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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 LOARGYS (pegzilarginase-nbln), approved February 23, 2026, manufactured by Immedica Pharma AB, meets the criteria for a priority review voucher.
Full Text
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<title>Federal Register, Volume 91 Issue 66 (Tuesday, April 7, 2026)</title>
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[Federal Register Volume 91, Number 66 (Tuesday, April 7, 2026)]
[Notices]
[Page 17660]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA-2026-N-3058]
Issuance of Priority Review Voucher; Rare Pediatric Disease
Product; LOARGYS (pegzilarginase-nbln)
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 LOARGYS (pegzilarginase-nbln), approved February 23, 2026,
manufactured by Immedica Pharma AB, 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#91c0e4e8f4ffbfc5e3f0ffa0d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="7b2a0e021e15552f091a154a3b1d1f1a55131308551c140d">[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 LOARGYS (pegzilarginase-nbln), manufactured by
Immedica Pharma AB, meets the criteria for a priority review voucher.
LOARGYS (pegzilarginase-nbln) injection is indicated for the treatment
of hyperargininemia in adult and pediatric patients 2 years of age and
older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary
protein restriction.
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 LOARGYS (pegzilarginase-nbln), 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. 2026-06722 Filed 4-6-26; 8:45 am]
BILLING CODE 4164-01-P
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