CHMP gave a positive opinion for Chiesi’s orphan drug

| By | Drug Quality Control, EMA

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, 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. The applicant for this medicinal product is Chiesi Farmaceutici S.p.A.

Lamzede will be available as 10 mg powder for solution for infusion. The active substance of Lamzede is velmanase alfa, 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.

Chiesi Pharmaceutici, an international company based in Parma, Italy, has more 80 years of experience and a strong focus on research, development, production and the commercialisation of innovative medicines in the respiratory, neonatology, rare disease and special care therapeutic areas. Its R&D centres in Parma (Italy), Paris (France), Cary (USA), Chippenham and Oxford (UK) and the R&D team from the Danish company Zymenex, integrate their efforts to advance Chiesi’s pre-clinical, clinical and registration programmes.