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Daiichi Sankyo To Apply For Approval For Second-gen Flu Drug In 2009

This article was originally published in PharmAsia News

Executive Summary

Daiichi Sankyo aims to complete its multicenter Phase III trial for flu drug CS-8958 this spring and apply for new drug approval in 2009. Commencing in November, the trial is being conducted in Japan, Taiwan, Hong Kong and Korea and is expected to complete by March. CS-8958 is a follow-on long acting neuraminidase inhibitor to Relenza (zanamivir), which was developed by Australian biotech Biota and marketed by GlaxoSmithKline (PharmAsia News, Aug. 3, 2008). In 2003 Biota and Daiichi combined their LANI research programs, including CS-8958 and a number of other LANI compounds such as FluNet, which are co-owned by Biota and Daiichi Sankyo. Compared to Roche's Tamiflu (oseltamivir) and Relenza, which require twice daily and five day administration, CS-8958 requires once-daily administration. As the current flu season started earlier and more patients have trialed CS-8958 20 mg and 40mg, the trial has progressed faster than anticipated. (Click here for more - Japanese language
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