Two multiple sclerosis drugs receive positive recommendation by EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion regarding the approval of two multiple sclerosis drugs.

One, developed by Sanofi's Genzyme, is the once-daily oral Aubagio (teriflunomide) for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS).

“The fact that AUBAGIO 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,”

Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland.

Aubagio has already been approved to treat relapsing MS in the United States and Australia. Genzyme are now waiting to hear about approval for treatment in Europe. The European Commission usually follows the EMA committee’s advice.

The second drug to receive a positive approval recommendation is Biogen's Tecfidera, which is sone of the first therapies for multiple sclerosis available in an easy-to-take pill. Some analysts believe Tecfidera may generate US $3.25 billion in annual sales.

There are approximately 630,000 people affected by MS in Europe and around 2.1 million worldwide.