Peramivir and its use in H1N1 influenza

Abstract

A novel H1N1 influenza virus of swine origin has emerged, causing the first pandemic of the 21st century. Infections with 2009 pandemic influenza A (H1N1) are typically moderate. However, in rare cases, respiratory distress, neurological complications and death have been reported. To alleviate complications associated with 2009 H1N1 influenza infection, the neuraminidase (NA) inhibitors oseltamivir (oral) and zanamivir (inhaled) are recommended. Hospitalized patients with severe complications may not respond to these drugs or be able to receive oral antiviral therapy, and therefore, parenteral formulations that would allow rapid delivery at high concentrations are being pursued. Peramivir is a novel potent NA inhibitor currently in clinical trials for intravenous (i.v.) administration. In clinical trials, i.v. peramivir was shown to be safe and well tolerated, with a pharmacokinetic profile that supports once-daily dosing. Based on the safety and efficacy of i.v. peramivir in clinical trials and the need for a parenteral antiviral, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the use of peramivir for the treatment of hospitalized patients with known or suspected 2009 H1N1 influenza infection. In Japan, peramivir has been licensed under the name Rapiacta. The development of peramivir leading to the issuance of the EUA and approval in Japan will be discussed.