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news.US biotechnology firm Genzyme is seeking approval from the FDA for its Myozyme drug in the treatment of Pompe disease, a debilitating muscle disorder resulting from an inherited enzyme deficiency.
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The company said its application is expected to receive “priority review” status by the FDA, which means the agency would be required to act on the application within six months.
In clinical trials, the drug showed that it was able to prolong patient lives and free them of ventilator support at 18 months of age.
Genzyme plans to submit results from the study to the European Medicines Agency, which is reviewing a marketing authorization application for Myozyme filed in December 2004.
The company hopes its product will be available in the US and Europe by the early part of next year. It also anticipates submitting a marketing application for Myozyme in Japan later this year.