EU CHMP recommends approval of Lamzede for alpha-mannosidosis.- Chiesi

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lamzede (velmanase alfa), from Chiesi, intended for the treatment of patients with non-neurological manifestations of mild to moderate alpha-mannosidosis. Lamzede was designated as an orphan medicinal product on 26 January 2005. Lamzede will be available as 10 mg powder for solution for infusion. The active substance of Lamzede is a recombinant form of human alpha-mannosidase. Lamzede is an enzyme replacement therapy intended to provide or supplement natural alpha-mannosidase, an enzyme that helps with the degradation of mannose–rich oligosaccharides and thus prevents their accumulation in various tissues in the body.

The benefits of Lamzede are its ability to restore serum oligosaccharides to normal levels and improve exercise capacity and lung function in some patients. The most common side effects are diarrhoea, fever and weight increase. The full indication is: “Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.”