MADRID, 27 ( EUROPA PRESS)
The European Medicines Agency ( EMA, by its acronym in English) has accepted the dossier of application for authorisation for marketing of oral teriflunomida, once a day, for the treatment of forms tumors of multiple sclerosis (MS), as announced Monday by Genzyme.
Assistant Vice President and head of multiple sclerosis in Genzyme, Bill Sibold, pointed out that “it represents another important milestone for teriflunomida” and placed to the company “more closely than to offer a new therapeutic option for patients with relapsing MS”.
“As oral treatment with a promising clinical profile, the teriflunomida is extremely well positioned to compete with injectable treatments, which constitute approximately 80 per cent of the market of Ms”, explained.
The application is based on data from two completed fundamental phase III trials, TEMSO and TENERE. These trials are two of the five studies of effectiveness of teriflunomida in Ma that are terminated or ongoing, making this program clinical one of the more extensive and far-reaching for any treatment in development for MS
The American Drug Agency (FDA) is reviewing a request for marketing of teriflunomida.
Teriflunomida is a drug administered by oral route, immunomodulator and modifier of the disease with anti-inflammatory properties, which is under investigation for the treatment of Ms. The teriflunomida prevents the proliferation and the operation of activated T and B lymphocytes believed that they are particularly harmful in MS, by inhibiting mitochondrial enzyme in a selective and reversible way.
