Lamzede FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2023.
FDA Approved: Yes (First approved February 16, 2023)
Brand name: Lamzede
Generic name: velmanase alfa-tycv
Dosage form: Lyophilized Powder for Injection
Company: Chiesi Global Rare Diseases
Treatment for: Alpha-Mannosidosis
Lamzede (velmanase-alfa-tycv) is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis.
- Alpha-mannosidosis is an ultra-rare, progressive lysosomal storage disorder caused by a deficiency of the enzyme alpha-mannosidase, an enzyme that is involved in the degradation of mannose-rich oligosaccharides to prevent their accumulation in various tissues in the body. The buildup of the oligosaccharides can affect many of the body's organs and systems, and symptoms include recurrent chest and ear infections, hearing loss, distinctive facial features, muscle weakness, skeletal and joint abnormalities, visual abnormalities, and cognitive abnormalities.
- Lamzede is a recombinant form of human alpha-mannosidase intended to provide or supplement natural alpha-mannosidase.
- Lamzede is administered via intravenous infusion once every week.
- Lamzede carries a Boxed Warning for severe hypersensitivity reactions including anaphylaxis. Warnings and precautions associated with Lamzede include infusion-associated reactions (IARs) and embryo-fetal toxicity.
- Common adverse reactions include hypersensitivity reactions including anaphylaxis, nasopharyngitis, pyrexia, headache, and arthralgia.
Development timeline for Lamzede
| Date | Article |
|---|---|
| Feb 16, 2023 | Approval FDA Approves Lamzede (velmanase alfa-tycv) for the Treatment of Alpha-Mannosidosis |
Further information
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