PARIS--The U.S. Food and Drug Administration, or FDA, granted
fast-track designation for the development of a new drug aimed at
treating Fabry disease developed by biotech Genzyme, according to
its parent company French pharmaceutical giant Sanofi SA
(SAN.FR).
Genzyme is currently enrolling patients for its phase 2a trial
for the drug currently named GZ/SAR402671, which is designed to
treat Fabry disease, a rare genetic lysosomal storage disease that
can cause a wide range of systemic symptoms for the about 10,000
diagnosed patients in the world, Sanofi said Tuesday.
FDA's Fast Track Designation is a program designed to ease
contacts between a drug firm and its teams to make the approval
process faster for medicines with the potential to treat serious or
life-threatening conditions. The company also plans to enroll nine
treatment-naïve male adult patients with Fabry disease.
The effort to develop the new drug is part of a Sanofi strategy
to develop efficient, and potentially lucrative, therapies for rare
diseases.
-Write to Inti Landauro at inti.landauro@wsj.com
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