4 April 2018 - Lamzede (velmanase alfa) is the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha‑mannosidosis.

Chiesi today announced that the European Commission has granted the marketing authorisation for Lamzede (velmanase alfa), the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha‑mannosidosis, an ultra-rare progressive and debilitating disease. As a result of this marketing authorisation, Velmanase alfa is now approved for use in the 31 European countries covered by the EMA.

The Marketing Authorisation has been granted under “exceptional circumstances” according to the EU legislation, which aim to enable treatment of extremely rare disorders for which traditional large-scale clinical studies are not feasible. Velmanase alfa has been investigated in 34 patients, both children and adults.

Read Chiesi press release