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# FDA OKs Chiesi’s Lamzede for Alpha-Mannosidosis
- URL: https://www.fdaweb.com/fda-oks-chiesis-lamzede-for-alpha-mannosidosis/
- Published: 2023-02-17T12:00:00.000Z
- Updated: 2026-09-14T18:16:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153804

FDA has approved Chiesi Global Rare Diseases’ Lamzede (velmanase alfa-tycv) to treat non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. The company [says](https://www.prnewswire.com/news-releases/chiesi-global-rare-diseases-announces-fda-approval-of-lamzedevelmanase-alfa-tycv-for-alpha-mannosidosis-301749440.html?ref=fdaweb.com) Lamzede is a recombinant form of human alpha-mannosidase intended to provide or supplement natural alpha-mannosidase, an enzyme that is involved in the degradation of mannose-rich oligosaccharides to prevent their accumulation in various tissues in the body.

In an [announcement](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-enzyme-replacement-therapy-rare-alpha-mannosidosis?utm%5Fmedium=email&utm%5Fsource=govdelivery), FDA says patients receive Lamzede as an injection once a week. The drug’s effectiveness was evaluated in adults and pediatric patients in a Phase 3 parallel group study. FDA says the most common adverse reactions to Lamzede are hypersensitivity reactions. Lamzede received orphan drug designation from FDA for this indication.