a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
that the U.S. Food and Drug Administration (FDA) has approved 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 CEO, Genzyme. "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."
The FDA approval was based on efficacy data from the TEMSO (riflunomide ultiple clerosis ral) trial. In the Phase III TEMSO trial, AUBAGIO 14 mg significantly reduced the annualized relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis. AUBAGIO 7 mg significantly reduced the annualized relapse rate (p=0.0002) in the trial.
"Many people living with MS struggle with the additional burden of
injectable therapies administered daily to weekly," said Dr. Aaron
E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for
Multiple Sclerosis, Mount Sinai Medical Center. "The FDA's approval
of AUBAGIO, a new oral treatment option, is an encouraging advancement
for the MS community and may be a valuable treatment for people living
with this often debilitating disease."
The ongoing AUBAGIO clinical development program, involving more than
5,000 patients in 36 countries, is amongst the largest of any MS
therapy. Some patients in extension trials have been treated for up to