Genzyme's Myozyme gets EU go-ahead

USA-based biotechnology firm Genzyme says it has been granted marketing authorization for Myozyme (alglucosidase alfa), for the treatment of Pompe disease, in the European Union. The condition, which is also known as acid maltase deficiency, is a debilitating and progressive lysosomal storage disorder which manifests as increasing muscle weakness and breathing difficulty. Currently, the illness affects fewer than 10,000 people worldwide.

The product, which has received Orphan Drug designation in Europe, is a long-term enzyme replacement therapy for patients with confirmed cases of the disease. Genzyme says it will introduce the drug on a country by country basis when it has obtained the required pricing and reimbursement approvals.

Ria Broekgaarden, secretary of the International Pompe Association, said that the organization welcomed the approval announcement and added that it represented hope for sufferers. Genzyme's share price rose $0.31 to $67.53 during midday trading on the Nasdaq on the day of the news, April 3.