19 November 2012 | Regulatory | By BioSpectrum Bureau
Daiichi Sankyo seeks approval for influenza antiviral product Inavir Dry Powder Inhaler in Japan
The safety and efficacy of Inavir was confirmed in phase III clinical trials
Singapore: Daiichi Sankyo has submitted an application for a partial label change in Japan to manufacture and market the influenza antiviral product Inavir Dry Powder Inhaler (laninamivir octanoate hydrate) for prevention of influenza infection.
Inavir is a long-acting neuraminidase inhibitor with therapeutic efficacy after single dosage and was developed and produced by Daiichi Sankyo. The drug received approval for manufacture and marketing for treatment of influenza A and B viruses in Japan on September 10, 2010, and was launched on October 19, 2010.
The safety and efficacy of Inavir in the prevention of influenza virus infection among household contacts of patients with influenza A or B virus infection was confirmed in phase III clinical trials. This application in Japan for the prevention of Influenza infection is based on those results.