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news.Genzyme has submitted marketing applications in both the US and the European Union for Mozobil, a product candidate intended to enhance mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.
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The company has requested priority review of its US application and, if granted, Mozobil could be approved by the end of 2008. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.
Genzyme conducted two Phase III studies that confirmed the potential of Mozobil to effectively and predictably prepare lymphoma and multiple myeloma patients for an autologous transplant. Both studies successfully met primary and secondary endpoints.
Mark Goldberg, managing director and senior vice president of clinical research at Genzyme, said: “The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients.”