BioCryst Provides Updates On Peramivir For Influenza Patients

BioCryst Pharmaceuticals has delivered a written response to the request for proposal (RFP) announced on September 21, 2009 from the US Department of Health & Human Services (HHS) for the supply of intravenous (iv) peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization (EUA).

The company said that it is initiating two phase 3 studies of iv peramivir for the treatment of hospitalised patients with serious influenza. These studies are intended to support US regulatory approval of peramivir as a treatment for influenza.

According to the company, one phase 3 study is a multicenter, randomised, double-blind, controlled study to evaluate the efficacy and safety of iv Peramivir.

The company said that the other phase 3 study is an open-label, randomised study of the anti-viral activity, safety and tolerability of iv peramivir 600mg.

William Sheridan, chief medical officer at BioCryst, said: “BioCryst is pleased to be able to proceed with the first phase 3 studies of an anti-viral agent ever conducted in influenza patients requiring hospitalisation. The need for such studies is clear; there are currently no anti-viral agents approved for this seriously ill patient population, and no intravenous or injectable forms of any anti-viral agent are approved for any influenza indication.”