Regulatory approval briefs: Betaferon in China; new use for Lilly's Cymbalta in USA; update on telavancin

German drug major Bayer Schering Pharma said today 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 already available in more than 100 countries around the world.

Habib Dable, global head of Neurology/Ophthalmology at Bayer Schering, said: '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 euros ($149 million) 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 that from Betaferon studies in different patient populations and with Bayer's post-marketing experience.

Separately, US drug major Eli Lilly announced yesterday that Cymbalta (duloxetine HCl) has received approval from the US Food and Drug Administration for the maintenance treatment of generalized anxiety disorder in adults.