Hørsholm - September 2, 2013 - Today, the European Medicines Agency has authorized Genzyme, a Sanofi company, to market Aubagio® (teriflunomide) 14 mg, a daily tablet treatment approved for adult patients with Recurring-Remitting Multiple Sclerosis (RRMS, perhaps sclerosis) ).
Hørsholm - September 2, 2013- The European Medicines Agency has given today Genzyme, and Sanofi company, license to market Aubagio®(teriflunomide) 14 mg, a daily tablet treatment approved for adult patients with Recurrent-Remitting Multiple Sclerosis (RRMS, perhaps sclerosis).
The European approval of Aubagio is based on data from two Phase III studies: TEMSO (TEriflunomideMultiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE sclerodomaRosis). In both studies, Aubagio reduced the annual attacrate and exposed the time to disease worsening compared to placebo.
"Aubagio's efficacy, adverse reaction profile and patient-friendly mode of administration represent an attractive treatment option for patients,"says Genzyme's Danish country manager Lis Callesen. "The approval of Aubagio is an important step forward for Genzyme in our work to develop new treatments that can meet some of the unmet needs that are in the area of multiple sclerosis."
The development of Aubagio represents more than 10 years of work in Sanofi's research and development department. Aubagio is approved and marketed for the treatment of incidental sclerosis in i.a. USA and Australia. With the European approval, Danish sclerosis patients can now also benefit and benefit from the treatment. About 12.500 Danes have sclerosis. 700 are diagnosed each year.
Aubagio is an immune modulator with anti-inflammatory properties. Although the precise mechanism of action of Aubagio is not fully uncovered, it is thought to involve a reduction in the number of activated lymphocytes in the central nervous system. Aubagios developed through one of the largest clinical programs in MS treatment with more than 5,000 patients in 36 countries, some of whom have been treated for up to 10 years.
In the clinical studies of Aubagio, the incidence of serious adverse events was comparable between those treated with Aubagio and those treated with placebo. The most common side effects with Aubagio were increased ALT levels, hair thinning, diarrhea, flu, nausea and palsy.
For the full product summary see:
Om Genzyme, and Sanofi company
For more than 30 years, Genzyme has been a pioneer in the development and distribution of cutting-edge treatments for patients suffering from rare and debilitating diseases. We achieve our goals through leading research and through the compassion and commitment of our employees. Focusing on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we work for. This goal guides us and inspires us every single day. Genzyme's portfolio of cutting-edge therapies, marketed in countries around the world, represents landmark advances in drug development. As part of Sanofi, Genzyme benefits from the resources of one of the world's largest pharmaceutical companies, which shares the commitment to improving the lives of patients. read more on www.genzyme.dk.
Sanofi, one of the world's leading pharmaceutical companies, develops, creates and distributes treatments focused on patients' needs. Sanofi has core competencies in pharmaceuticals, focusing on seven areas: Diabetes, vaccines, innovative drugs, over-the-counter medicines, emerging markets, animal welfare and the new Genzyme. Sanofi is listed on the Paris stock exchanges (EURONEXT: SAN) and New York (NYSE: SNY).
Source: Sclerosis Association