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This study, named Marvel, was performed as a randomized, double-blind, and active-controlled study in order to confirm the efficacy and safety of CS-8958 administered as a single inhaled dose of 20 or 40mg compared to oseltamivir phosphate 75mg orally administered twice daily for five days (total of 10 times) in adult patients with influenza A or B virus infection.
According to the study results, non-inferiority to oseltamivir phosphate was confirmed in both the 20mg group and 40mg group of CS-8958 in terms of the primary endpoint, which was the time to alleviation of influenza illness. In the comparison between the dose groups of CS-8958, 40mg group was superior to 20mg group in efficacy. Both 20mg and 40mg of CS-8958 were well tolerated.
In addition, Daiichi Sankyo conducted a randomized, double-blind, active-controlled Phase II/III study for pediatric use in parallel with Marvel study, and the efficacy and safety of CS-8958 administered as a single inhaled dose of 20 or 40mg was compared to oseltamivir phosphate as well. According to the results, both the 20mg group and 40mg group of CS-8958 were better than oseltamivir phosphate group in efficacy. Both 20mg and 40mg of CS-8958 were well tolerated in pediatric patients.
Daiichi Sankyo is now preparing to file its new drug application for a treatment indication in fiscal year 2009. Furthermore, Daiichi Sankyo is also preparing to start a clinical study for a prophylaxis indication in autumn of 2009.
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