FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements

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FDA expands approval of drug to treat Pompe disease to patients of all ages; removes risk mitigation strategy requirements

08/01/2014 01:33 PM EDT

The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.

 

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