FDA Grants Emergency Use Authorisation To Peramivir

BioCryst has announced that the FDA, has issued an Emergency Use Authorisation (EUA) for the investigational anti-viral drug intravenous iv Peramivir in certain adult and pediatric patients with confirmed or suspected H1N1 influenza infection who are admitted to a hospital. This action was taken in response to a request from the US Centers for Disease Control and Prevention (CDC).

iv Peramivir is authorised only for hospitalised adult and pediatric patients for whom therapy with an iv drug is clinically appropriate. It is approved to be administered to patients not responding to either oral or inhaled anti-viral therapy; when drug delivery by a route other than an intravenous route is not expected to be dependable or feasible or for adults when the clinician judges iv therapy is appropriate due to other circumstances.

Jon Stonehouse, chief executive officer at BioCryst, said: “The issuance of this EUA is important because it makes Peramivir a treatment option for physicians in the US during the ongoing influenza health emergency. BioCryst has worked with HHS to enable the Government to rapidly deploy an initial supply of Peramivir, and we are prepared to deliver more.”

Peramivir is an anti-viral agent, which inhibits the interactions of influenza neuraminidase.