The Chinese State Food and Drug Administration (SFDA) has approved Bayer Schering Pharma\'s 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.
Habib Dable, global head of neurology/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. 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 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 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.