EMEA prioriatizes Myozyme access

26 January 2009

The European Medicines Agency's (EMEA) Committee for Medicinal Products (CHMP) has recommended that infants, children and adolescents be given  priority access to Myozyme (alglucosidase alfa), from USA-based Genzyme,  during the expected supply shortage of the product over the next few  months. This is intended to ensure that these patients continue to  receive the drug while the company solves its problems.

The supply shortage has been caused by the demand for Myozyme outgrowing  current manufacturing capacity, as well as issues with the production of  the medicine at some of the firm's sites. While these difficulties are  under investigation and Genzyme takes steps to extend its manufacturing  facilities, the temporary treatment recommendations will help doctors to  manage potential interruptions in supply, says the CHMP.

Myozyme is used to treat patients with Pompe disease, a rare, inherited  enzyme-deficiency disorder, which leads to a progressive build-up of  glycogen in certain tissues, particularly the heart and other muscles.

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