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Interferon Beta-1b Approved in China for Multiple Sclerosis BERLIN -- December 2, 2009 -- The Chinese State Food and Drug Administration (SFDA) has approved interferon beta-1b (Betaferon) for patients with relapsing-remitting multiple sclerosis (MS). The approval is based on established efficacy and safety data from pivotal clinical trials of interferon beta-1b, along with findings from a single-arm study designed to demonstrate the efficacy and safety of the drug among Chinese patients with relapsing-remitting MS. During the multicentre 6-month study, interferon beta-1b significantly decreased the number of newly active lesions on MRI in Chinese patients. The data in MS patients from China is comparable with data from interferon beta-1b studies in different patient populations and with Bayer’s post-marketing experience. In the multicentre, single-arm, open-label study, 39 patients were enrolled into a 3-month pre-treatment phase followed by a 6-month treatment phase. The primary efficacy endpoint was the number of newly active lesions during 6 months on therapy. Newly active lesions were defined as new T1 Gd-enhancing lesions and non-enhancing T1 lesions appearing new (or enlarged) on T2-weighted scans at months 3 and 6 (cumulative 6-month number divided by 2), compared to the number of newly active lesions during a 3-month pre-treatment period. In the treatment period, significant decreases were observed for the primary endpoint. The mean number of newly active lesions in the pretreatment group was 4.77, versus the 1.55 in the treatment group (P < .0001). Adverse events (AEs) were usually self-limiting and mild or moderate. The most frequent AEs were flu-like-symptoms, injection-site reactions, and hepatic function abnormality. None of the patients discontinued treatment because of AEs or laboratory toxicity. SOURCE: Bayer Schering Pharma AG E-mail this page to a friend or colleague! To print, use this version