CHMP Recommends Approval of New Formulation of Rebif

June 29, 2007

Merck KGaA announced that the Committee for Medicinal Products for Human Use issued a positive opinion recommending marketing authorization of a new formulation of Rebif for the treatment of relapsing multiple sclerosis (MS).

The new formulation of Rebif (interferon beta-1a) was developed by the Merck Serono division to increase treatment benefit by improving injection tolerability and reducing immunogenicity, Merck said.

Rebif was originally approved in Europe in 1998, has been proven effective on the following three key measures of treatment effectiveness: MRI lesion area and activity, relapse rates and disability progression, the company said.

The data from a 48-week study showed that the rate of injection-site reactions in patients with MS who received the new formulation of Rebif was three times lower when compared with data from previous trials. The data also showed that 13.9 percent of patients treated with the new formulation of Rebif had neutralizing antibodies after one-year of treatment, according to the company.

The results at one year showed that patients who tested positive for neutralizing antibodies at both the 24- and 48-week time points represented 2.5 percent of the patients, the company said.