Betaferon® approved in China for treatment of Multiple Sclerosis
Bayer Schering Pharma AG announced that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon® (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010.
Betaferon is available in more than 100 countries around the world. "This approval is good news for MS patients in China, allowing them access to Betaferon, that has been demonstrated to modify the course of MS," said Habib Dable, Global Head, Neurology/Ophthalmology of Bayer Schering Pharma AG. "The approval of Betaferon in China underscores Bayer's ongoing commitment to address the unmet medical needs of people around the world.
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With the foundation of a research and development center in Beijing in February 2009, Bayer has strengthened its engagement in the Region. In the upcoming five years, a total of 100 million Euro is planned to be invested in a center for clinical research in Beijing." The approval is based on established efficacy and safety data from pivotal Betaferon clinical trials, along with findings from a single-arm study designed to demonstrate the efficacy and safety of Betaferon among Chinese patients with relapsing-remitting MS.
During the multi-center six-month study, Betaferon 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 Betaferon studies in different patient populations and with Bayer's post-marketing experience.
About the Betaferon study in China
In the multicenter single-arm open label study, 39 patients were enrolled into a three-month pre-treatment phase followed by a six-month treatment phase. The primary efficacy endpoint was the number of newly active lesions during six 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 three and six (cumulative six-month number divided by two), compared to the number of newly active lesions during a three-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, vs. the 1.55 in the treatment group (p<0.0001). 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 (01/12/09)
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