, aSanofi 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).
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.
said Genzyme CEO and President David Meeker, MD.
The CHMP did not recommend that AUBAGIO receive a new active substance (NAS) designation.
Additional marketing applications for AUBAGIO are under review by regulatory authorities around the world.
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).
AUBAGIO (teriflunomide) is a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). AUBAGIO 14 mg 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.
The AUBAGIO U.S. label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data).
In MS clinical studies with AUBAGIO, the incidence of serious adverse events were similar among AUBAGIO and placebo-treated patients. The most common adverse events associated with AUBAGIO in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia. Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. and Europe for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.
Leflunomide has an estimated 2.1 million patient years of exposure in rheumatoid arthritis globally since its launch.
AUBAGIO is contraindicated in pregnant women and women of childbearing potential who are not using reliable contraception.
AUBAGIO is supported by a robust clinical program with more than 5,000 trial participants in 36 countries and is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years. The EU AUBAGIO submission includes efficacy data from the TOWER (eriflunomide ral in people ith relapsing remitting multipl scleosis) and TEMSO (riflunomide ultiple clerosis ral) trials.
For full prescribing information and more information about AUBAGIO, please visit .
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at .
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).