April 3rd, 2006 - European Commission Approves Genzyme’s Myozyme®
Product is First Treatment for Pompe Disease
Genzyme Corp. (Nasdaq: GENZ) announced today that it has received marketing authorization for Myozyme (alglucosidase alfa) in the European Union. Myozyme has been approved for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Pompe disease, a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. The product is the first treatment ever approved for Pompe disease and one of the first for an inherited muscle disorder.
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2nd March 2009 - UPDATE ON SUPPLY OF MYOZYME
We are pleased to inform you that the European Commission has approved the larger 4000 L scale production of Myozyme at Genzyme’s manufacturing facility in Belgium for use within the European Union. With this approval, the demand on the 2000 L inventories that currently supply the rest of the world, including MTAP in the US, has been relieved and the supply constraint is now resolved. The larger-scale Belgium facility will be able to help meet the long-term needs of patients for Myozyme upon receipt of approval by regulatory agencies throughout the world.
March, 2008 - AUSTRALIAN TGA APPROVES MYOZYME
On Friday, 14th March 2008, Myozyme received marketing approval from the TGA., for the long-term treatment of patients with a confirmed diagnosis of Pompe disease (acid alfa-glucosidase deficiency).
September 26, 2006 - Special Award for Orphan Drug
Genzyme earned its special Prix Galien medal for Myozyme, the first enzyme replacement therapy to target a neuromuscular disorder. Classified as an ultra orphan drug Myozyme provides a treatment option for Pompe Disease.
April 28, 2006 - Treatment is now available for Pompe’s Disease
The Food and Drug Administration today granted marketing approval for Myozyme (alglucosidase alfa) in the USA.
April 28, 2006 - FDA Approves Genzyme’s Myozyme® For All Patients With Pompe Disease
Genzyme Corp. (Nasdaq: GENZ) announced today that the Food and Drug Administration has granted marketing approval for Myozyme (alglucosidase alfa) in the United States. Myozyme has been approved for the treatment of patients with Pompe disease, a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. The product is the first treatment ever approved for Pompe disease and the first for an inherited muscle disorder.
"This is a special day for people across the Pompe community and at Genzyme, who have worked together for many years and overcome enormous challenges so that patients with this devastating disease now have a chance," said Henri A. Termeer, chairman and chief executive officer of Genzyme Corp.
April 3rd, 2006 - European Commission Approves Genzyme’s Myozyme®
Product is First Treatment for Pompe Disease
Genzyme Corp. (Nasdaq: GENZ) announced today that it has received marketing authorization for Myozyme (alglucosidase alfa) in the European Union. Myozyme has been approved for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Pompe disease, a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide. The product is the first treatment ever approved for Pompe disease and one of the first for an inherited muscle disorder.
July 5th, 2009. IPA Feedback Survey:
Response to Myozyme Supply Disruption
Results of an informal on-line and paper survey of the global community of sufferers of Pompe Disease, following a short interruption in the supply of their Enzyme Replacement Therapy, Myozyme.
