Genzyme's biologics license application for Myozyme receives review extension

By Lisa Kerner

Erie, Pa., Jan. 17 - Genzyme Corp. announced that the Food and Drug Administration has extended the review period for the biologics license application for Myozyme (alglucosidase alfa). The new action date for the application is April 28, 2006, according to a company release.

The purpose of the 90-day extension is to provide the FDA with sufficient time to review additional information submitted by Genzyme in late December. The information was submitted at the FDA's request.

"This is a brief extension of the review period, and we continue to expect that Myozyme will be approved in the United States during the first half of this year," Genzyme senior vice president for regulatory affairs Alison Lawton said in the release. "We have worked closely with the FDA throughout the review process and are confident the agency recognizes the urgency of making this treatment available to patients."

Genzyme submitted a biologics license application, which was given priority review status for Myozyme in late July.

Myozyme has been developed for the treatment of Pompe disease, a debilitating, progressive and often fatal muscular disorder.

Approximately 200 patients in 14 countries are currently receiving Myozyme through clinical trials, expanded access programs, or pre-approval regulatory mechanisms.

Genzyme's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. The company is based in Cambridge, Mass.

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