Home » Chiesi Group’s Lamzede Gets FDA Approval for Rare Genetic Disorder
Chiesi Group’s Lamzede Gets FDA Approval for Rare Genetic Disorder
The Chiesi Group has received FDA approval for Lamzede (velmanase alfa-tycv) for treatment of adult and pediatric patients with non-central nervous system manifestations of alpha-mannosidosis, a rare genetic disorder characterized by an inability to break down complex sugars.
Lamzede is a recombinant form of human alpha-mannosidase to provide or supplement natural alpha-mannosidase, an enzyme involved in degradation of mannose-rich oligosaccharides.
The FDA required a boxed warning with the product that some patients treated with Lamzede have experienced hypersensitivity reactions, including anaphylaxis.
Pretreatment with antihistamines, antipyretics and/or corticosteroids should be considered before administering Lamzede, the agency said.
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