Genzyme’s Alemtuzumab granted Fast Track Status
Genzyme Corporation announced that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.
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.
Alemtuzumab is currently being evaluated in two pivotal multi-center, multi-national trials. Data are expected to be available in 2011.
Source: Businesswire
