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Published on 25 September 2008

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US approval expected for Genzyme treatments

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Genzyme Corporation has provided updates on three therapies, with regulatory actions expected by the end of the year.

Genzyme Corporation expects the FDA to act on its biologic license application for Myozyme (alglucosidase alfa) by November 2008. The company also detailed how its new drug application for Mozobil (plerixafor) had been given prority review, with an action plan date set for December 2008, as too with their third application, Synvisc-One (hylan G-F 20).

Myozyme is currently under review to help treat a severe, progressively debilitating and life-threatening disorder called Pompe disease and a meeting is to be held in October by the FDA’s Endocrinologic and Metabolic Drugs advisory Committee. Discussions will be based on Genzyme Corporations biologic license application for the drug.

In the first half of the meeting in October, doors to the public will be closed and discussions wil focus on the proprietary manufacturing data . The second portion of the meeting – open for public access – will be the basis for the approval of the proposed labelled indication for the product and will look at data from Genzyme’s late-onset treatment study (LOTS).

Genzyme Senior Vice President Alison Lawton said: “We are confident that the strong clinical data from the LOTS trial will support US approval of alglucosidase alfa manufactured at the 2000L scale. We are working cooperatively with the FDA to move this process forward expeditiously so that we can provide broader access to treatment as soon as possible.”

Mozobil, specifically designed to mobilise haematopoietic stem cells from the bone marrow into the bloodstream, has been developed to make it more likely for patients with certain types of cancers to be able to receive a successful transplant.

Two phase III studies were conducted for Mozobil, the tests confirmed its potential to effectively and predictably prepare lymphoma and multiple myeloma patients for an autologous HSC transplant.

As well as testing for the effects the drug has as a form of treatment for Pompe disease, Myozyme will be evaluated on its safety and efficacy in adult patients.

Genzyme Corporation



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