FDA Fast Tracks Development of Sanofi Rare Disease Treatment

Published on: 

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.