Lamzede®▼ receives European marketing authorisation

Hannah Alderton 04 April 2018

Chiesi, a research-focussed healthcare group have 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 (AM), 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 European Medicines Agency (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.

 Alessandro Chiesi, Region Europe Head, Chiesi Group  said, “Lamzede is the first approved treatment with disease modifying potential for alpha-mannosidosis and therefore, our next goal is to make this treatment available to patients in Europe as soon as possible,”

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