To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: European Committee Recommends Betaseron For Secondary Progressive MS URL: http://www.pslgroup.com/dg/BABEA.htm Doctor's Guide October 30, 1998
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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.