FDAnews
www.fdanews.com/articles/110629-primary-endpoint-met-in-merck-serono-rsquo-s-ms-trial

Primary Endpoint Met in Merck Serono’s MS Trial

September 23, 2008

Merck Serono received promising findings from its Phase IIIb study using a new formulation of Rebif in patients with relapsing-remitting multiple sclerosis (MS).

The two-arm, randomized, double-blind, controlled, multicenter, international study evaluated the efficacy, safety and tolerability of the drug in 180 patients.

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was lower in patients treated with the drug than in patients who received a placebo. The mean number of combined unique active brain lesions per patient was reduced by 69 percent in patients treated with the drug, Merck said.