Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of 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,” said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland.
There are approximately 630,000 people affected by MS in Europe. AUBAGIO is approved to treat relapsing MS in the United States and Australia.
“This positive CHMP opinion and broad recommended indication reflect the strong data from AUBAGIO’s clinical development program. As we’ve seen from the uptake of AUBAGIO in the United States, many patients are looking for an alternative to current injectable therapies,” said Genzyme CEO and President David Meeker, MD.The CHMP did not recommend that AUBAGIO receive a new active substance (NAS) designation. “We are very disappointed about the CHMP opinion regarding new active substance designation. We believe based on the product’s characteristics and current data that AUBAGIO is a new active substance,” added Meeker. “AUBAGIO has been studied over 10 years in one of the largest and broadest clinical development programs of any MS therapy. This decision could have a detrimental impact on future scientific innovation in MS and other diseases. We are considering all options and planning to request a re-examination of the new active substance designation.” Additional marketing applications for AUBAGIO are under review by regulatory authorities around the world. About AUBAGIO® AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).