FDA Fast Tracks Development of Sanofi Rare Disease Treatment

April 28, 2015.

Sanofi and its subsidiary Genzyme have gained FDA Fast Track designation for the development of its new treatment for Fabry disease, a progressive condition characterized by excessive accumulation of the lipid GL-3 in various organs and tissues. There are approximately 10,000 diagnosed patients in the world; patients with Fabry disease typically have a shortened life span.   FDA's Fast Track Drug Development Program is designed expedite the clinical development and review of a New Drug Application (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs for such diseases or conditions.