FDA Grants Fast Track Status Genzyme's Alemtuzumab for MS Treatment

June 14, 2010

US Food and Drug Administration has granted fast track status to Cambridge, MA-based Genzyme Corporationhas been granted fast track status by the FDA for its alemtuzumab for multiple sclerosis (MS) development program.

US Food and Drug Administration has granted fast track status to Cambridge, MA-based Genzyme Corporation for its alemtuzumab for multiple sclerosis (MS) development program. This designation covers patients with relapsing-remitting forms of the disease.

Alemtuzumab is licensed in the US as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside of the US for the treatment of B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate. The product was launched in its oncology indication in 2001 in the US, where it is marketed as Campath, and in Europe, where it is named MabCampath.

The FDA's fast track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Under fast track designation, alemtuzumab for MS is eligible for priority review and the FDA may consider for review portions of the marketing application before the submission of a new drug application is completed.