Teriflunomide

• Parent company: Sanofi-aventis.


• Oral medication taken daily.


• This drug is an immunomodulator, affecting the division of T cells.


• A Phase II trial of RRMS patients with relapses evaluated two dose levels versus placebo. The treated groups had significantly fewer enhancing lesions and a lower relapse rate; fewer patients in the high-dose group experienced an increase in disability versus placebo, and there was a trend toward more relapse-free patients. Treatment was well tolerated.


• Two Phase II combination studies are in progress; one of teriflunomide added to interferon beta; the other adding it to Copaxone. Both will evaluate tolerability and safety, the number of gadolinium-enhancing lesions, and burden of disease on MRI.


• A two-year Phase III study is recruiting participants who have had a first episode (CIS) consistent with MS. Its primary outcome measure is conversion to CDMS. Secondary measures include relapse rate, burden of disease and other MRI variables, and the proportion of patients who remain free of disability.