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news.Shionogi & Co (Shionogi) has received marketing and manufacturing approval of a novel anti-viral drug for influenza, 'Rapiacta 300mg Bag for Intravenous Drip Infusion' and 'Rapiacta 150mg Vial for Intravenous Drip Infusion' (generic name: peramivir), on January 13, 2010. It is scheduled to be launched pending its National Health Insurance (NHI) price listing.
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Rapiacta, licensed from US-based BioCryst Pharmaceuticals, has been developed by Shionogi in Japan. Shionogi received approval 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.
Shionogi has also completed a clinical study in pediatric patients with uncomplicated seasonal influenza and will file an additional application for the pediatric use of Rapiacta within by the end of the year.
The phase III multi-national Asian study for Rapiacta was conducted in Japan, Taiwan and Korea. Although the FDA issued an Emergency Use Authorization (EUA) in the US for intravenous administration of Peramivir last October (for the treatment of hospitalized adult and pediatric patients for whom therapy with an iv drug is clinically appropriate), the marketing and manufacturing approval of Rapiacta received by Shionogi in Japan is said to be the world’s first formal marketing authorization of this drug. Shionogi believes that Rapiacta represents an important therapeutic advance for patients with influenza.