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CAMBRIDGE, Mass., April 21 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA has informed the company of its opinion that Myozyme(R) (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale. Production at this larger scale has already been approved in more than 40 countries.
Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale, including patients who participated in the Late-Onset Treatment Study (LOTS), Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe. Myozyme is the only treatment for Pompe disease -- a severe, progressively debilitating and life-threatening inherited disorder affecting a very small number of people throughout the world.
The FDA will require Genzyme to submit a separate biologics license
application (BLA) to gain approval for Myozyme produced at the 2000L scale.
The agency proposed that Genzyme initiate a rolling BLA review process by
submitting results from the LOTS study. Genzyme expects the FDA to give the
BLA priority review and to act on the application by the end of this year.
The LOTS study, which met its co-primary efficacy endpoints, was undertaken
to evaluate the safety and efficacy of Myozyme in juvenile and adult
|SOURCE Genzyme Corporation|
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