French drugmaker Sanofi’s Genzyme unit said its potential multiple sclerosis treatment teriflunomide showed no statistical superiority in a late-stage study comparing it with patients taking the older drug Rebif.
Genzyme said the two-year study compared seven- and 14-milligram doses of its oral drug with the injectable Rebif, which is marketed by Merck KGaA of Germany, in 324 patients with relapsing forms of multiple sclerosis. The trial measured the risk of treatment failure, which meant the occurrence of a confirmed relapse or permanent treatment discontinuation.
Both teriflunomide doses were safe and well-tolerated.
Genzyme said the study is one of five testing the effectiveness of teriflunomide in multiple sclerosis. Genzyme will include results from the study in its application for European approval for the drug, which it expects to file in the first quarter. The U.S. Food and Drug Administration accepted the drug’s application for review in October.
Date: December 20, 2011
Source: Associated Press