FDA thumbs up for Sanofi's MS drug Aubagio

As has been largely expected, the US Food and Drug Administration yesterday approved marketing of French drug major Sanofi (Euronext SAN) subsidiary Genzyme’s Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

Aubagio has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.

“We are very excited to introduce Aubagio as a new treatment option that can make a difference in the lives of people with multiple sclerosis,” said David Meeker, president and chief executive of Genzyme, adding: “The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community.”