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Bayer wins Chinese approval for multiple sclerosis drug

From Datamonitor via COMTEX (December 3, 2009)

Bayer Schering Pharma has reported that the Chinese State Food and Drug Administration has approved Betaferon therapy for patients with relapsing-remitting multiple sclerosis or MS.

Bayer Schering Pharma plans to launch Betaferon in the Chinese market by mid-2010.

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. Betaferon is marketed in the US and Canada under the trademark Betaseron.

Habib Dable, global head of neurology and ophthalmology at Bayer Schering Pharma, said: "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. The approval of Betaferon in China underscores Bayer's ongoing commitment to address the unmet medical needs of people around the world."

Posted: December 2009