Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission has granted marketing authorization for Aubagio ® (teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).
“The fact that Aubagio 14 mg has demonstrated a positive effect on disability progression in two phase III clinical studies underscores its importance as a new treatment option for relapsing remitting MS patients," said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. "As a new once-daily, oral treatment option with well-characterized safety and tolerability, Aubagio could be an attractive option for patients dissatisfied with traditional injectable therapies."
The EU approval of Aubagio was based on data from the Phase III TEMSO ( TEriflunomide Multiple Sclerosis Oral) and TOWER ( Teriflunomide Oral in people With relapsing remitting multipl E scle Rosis) trials. In these trials, Aubagio significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo.
“Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option for patients,” said Genzyme CEO and President, David Meeker, M.D. “Today’s approval of Aubagio is another step forward for Genzyme as we work to develop important new treatments that can address the diverse needs of the MS community.”Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by MS in Europe. The development of Aubagio reflects more than a decade of work by the Sanofi R&D organization. Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies.