Genzyme Fabry drug in France under an ATU
Genzyme General, a division of Genzyme Corp, has begun treating patientsin France with Fabrazyme (agalsidase beta) under an Authorisation Temporaire d'utilization from the French medicines agency. The ATU allows patients with Fabry disease in France to receive treatment with the drug prior to full marketing authorization. Genzyme says that it has also secured reimbursement for Fabrazyme through the French Social Security system.
This is positive news for the company, which recently got the thumbs down for Fabrazyme from the US regulatory authorities (Marketletter January 1 & 8), along with Transkaryotic Therapies' Replagal (agalsidase alfa), while both companies were racing to get their respective products to market first.
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