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.