Rapiacta, an intravenous injection for treatment of influenza infection, was launched for adult use in Japan on January 27, 2010. Shionogi filed a NDA for adult use of Rapiacta as soon as it confirmed the safety and efficacy of the drug in clinical trials, and at the same time, the company started a clinical study in children last fall.
The submission of additional indications of both single and multiple dose administration in pediatric patients is based on the results of about 100 pediatric cases treated in the study.
Rapiacta is a novel anti-viral drug for influenza (neuraminidase inhibitor) for both single dose administration for adult uncomplicated seasonal influenza infection as well as single or multiple dose administration for adult patients at high-risk.
The company said that this drug is effective and expected to improve compliance against seasonal influenza virus infection with a single-dose administration as an outpatient treatment. It is also widely available for treatment of patients with severe and life-threatening influenza, and when oral treatments are not a viable alternative. Shionogi believes that Rapiacta represents an important therapeutic advance for patients with influenza.