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European Committee Recommends Betaseron For Secondary Progressive MS MONTVILLE, NJ -- Oct. 30, 1998 -- The European committee for proprietary medicinal products (CPMP) has issued a positive scientific opinion for use of Berlex Laboratories, Inc.’s Betaseron(R) (Interferon beta-1b) to treat people with secondary progressive multiple sclerosis (MS). The CPMP reached this opinion after careful review of data from a European clinical study using Betaseron to treat people with this more advanced form of MS. The CPMP opinion is an important milestone in the European regulatory review process. World-wide to date, no medical treatment has received marketing approval for the Secondary Progressive form of MS. Betaseron, which is currently indicated both in the U.S. and Europe to treat relapsing-remitting forms of MS, was the only therapy that reported a beneficial treatment effect in patients with secondary progressive MS. In this clinical study, patients treated with Betaseron showed a significant delay in disease progression and in disability, a reduced frequency of MS attacks and a delay in time to become wheelchair dependent. In the European Secondary Progressive MS trial, Betaseron demonstrated similar side effects as seen previously in other studies including flu-like symptoms, dyspnea, menstrual disorders, injection site reactions and injection site necrosis. The analyses did not reveal increases in depression, suicides or attempted suicides. The European clinical study included 718 patients with secondary progressive MS who completed a minimum of two years of treatment. The study was a double-blind, randomised, placebo-controlled trial, conducted in 12 European countries. All study participants on active drug received eight million International Units (MIUs) of Betaseron subcutaneously every-other-day. This is the same treatment schedule used for patients with relapsing-remitting MS. Related Links: Betaseron, Berlex Laboratories, Inc. E-mail this page to a friend or colleague! To print, use this version