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Expert Panel Recommends European Approval Of Mozobil

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Published: Jun 2, 2009 1:53 pm

The Committee for Human Medicinal Products of the European Medicines Agency has recommended that the stem cell transplant drug Mozobil (plerixafor) be approved for use in the European Union.

Mozobil is used for stem cells transplants in patients with blood cancers, specifically non-Hodgkin’s lymphoma and multiple myeloma. Combined with other drugs that stimulate the body's production of stem cells, Mozobil helps move stem cells from the bone marrow into the bloodstream, where they can be collected for subsequent transplants.

Traditionally, the collection of stem cells for transplantation has been a process that extends over multiple days.  Mozobil reduces the number of days required for the collection process.  It also reduces the number of patients who must undergo more than one collection procedure to generate enough stem cells for transplantation.

"For many patients with lymphoma or multiple myeloma, moving on to a transplant is their only hope for remission or a cure," said Gerhard Ehninger, Professor of Medicine at Dresden Technology University and Chairman of the German Society of Hematology and Oncology.  The availability of Mozobil will give many patients "an opportunity to achieve a timely and successful transplant,” said Prof. Ehninger.

The Committee’s opinion will be brought before the European Commission, which is expected to make a final decision on the authorization of the drug within 66 days. Approval by the European Commission would allow Mozobil to be marketed in all 27 European Union member states.

Mozobil has been approved for use in the United States since December, 2008. Genzyme, the company that markets Mozobil, plans to apply for approval to sell Mozobil in up to 60 other countries.

For more information, please see the related press release at the Genzyme Web site.

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