Sanofi's MS drug Aubagio gains final European approval

Following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the spring (The Pharma Letter March 25), French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme announced on Friday (August 30) that the European Commission has granted marketing authorization for Aubagio (teriflunomide) 14mg, 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 Ludwig Kappos, Chair of Neurology at 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," Prof Kappos added.

Aubagio is already approved to treat relapsing MS in the USA (The Pharma Letter September 23, 2012), Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies. Analysts at Credit Suisse forecast peak sales for Aubagio of $1.2 billion. However, there are more modest expectations from four analysts polled by Bloomberg of $330 million turnover for the drug in 2015. Aubagio has already seen strong uptake in the US market.