FDA Fast-Tracks Sanofi's New Drug for Fabry Disease

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 [e-mail]

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