FDAnews
www.fdanews.com/articles/113110-study-novartis-8217-fingolimod-superior-to-avonex

Study: Novartis’ Fingolimod Superior to Avonex

December 16, 2008
Novartis reported positive Phase III clinical trial data on its investigational multiple sclerosis (MS) treatment fingolimod, an oral medication shown to have superior efficacy in treating relapsing-remitting MS compared with Biogen Idec’s Avonex.

 

The TRANSFORMS study — a 1,292-patient, double-blind, head-to-head trial — tested two doses of the product against Avonex (interferon beta 1a) in subjects with relapsing-remitting MS.

 

The 0.5-mg dose of fingolimod showed a statistically significant 52 percent greater reduction in the risk of disease relapse after one year of treatment compared with Avonex and a 38 percent greater reduction in risk for the same endpoint for the 1.25-mg dose, Novartis said.