Federal Register #FDA-2026-N-3058

FDA Awards Priority Review Voucher for LOARGYS (pegzilarginase-nbln), a Rare Pediatric Disease Drug

This notice announces the FDA's award of a priority review voucher for LOARGYS (pegzilarginase-nbln), a rare pediatric disease drug manufactured by Immedica Pharma AB. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA), Center for Drug Evaluation and Research - OEM Highlight: - Immedica Pharma AB is the sole manufacturer of LOARGYS (pegzilarginase-nbln) - Products/Services Requested or Awarded: - LOARGYS (pegzilarginase-nbln) injection - Indicated for treatment of hyperargininemia in adults and children (2+ years) with Arginase 1 Deficiency (ARG1D), used with dietary protein restriction - No specific quantity or part number provided - Unique/Notable Requirements: - Product must be approved as a rare pediatric disease therapy under the Federal Food, Drug, and Cosmetic Act - Award is a priority review voucher, not a procurement of goods or services - Public notice is required by law - Additional Information: - HRSA is seeking public comment on Rural Health Care Services Outreach Program data collection (not directly related to the LOARGYS award) - Key Locations: - FDA Center for Drug Evaluation and Research, Silver Spring, MD - HRSA Information Collection Clearance Office, Rockville, MD

Description

The Food and Drug Administration (FDA) has announced the issuance of a priority review voucher to the sponsor of LOARGYS (pegzilarginase-nbln), a rare pediatric disease product approved on February 23, 2026. This voucher is awarded under the Federal Food, Drug, and Cosmetic Act to sponsors of approved rare pediatric disease product applications that meet specific criteria. LOARGYS is indicated for the treatment of hyperargininemia in patients aged 2 years and older with Arginase 1 Deficiency, alongside dietary protein restriction. The notice serves to inform the public of this award as required by law.

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