BioCryst Pharmaceuticals has announced that the new drug application (NDA) for its intravenous peramivir has been accepted for review by the US Food and Drug Administration (FDA).
In December 2013, BioCryst submitted its intravenous peramivir new drug application to the FDA. The FDA has now assigned a standard review time for the NDA, resulting in a Prescription Drug User Fee Act action date of 23 December 2014.
However, the company has been informed by the FDA that the administration, at this time, does not plan to hold an Advisory Committee review of the NDA.
BioCryst president and CEO Jon P Stonehouse said: "We believe the approval of peramivir and its mode of i.v. administration would benefit many influenza patients, including those who cannot tolerate treatment by oral or inhaled administration. BioCryst is preparing to make peramivir available in the US during the 2014-15 influenza season, provided approval is granted within that timeframe."
BioCryst completed a pre-NDA meeting with the FDA in June 2013 regarding peramivir and the company reached an agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission included results of 27 clinical trials in more than 2,700 subjects treated with peramivir.
An investigational anti-viral agent, peramivir rapidly delivers high plasma concentrations to the sites of infection.
It inhibits the interactions of influenza neuraminidase, an enzyme that is critical to the spread of influenza within a host.
In laboratory tests, the drug demonstrated activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains.
BioCryst discovered peramivir and it has been developed under a $234.8m contract from BARDA/HHS. In January 2010, Shionogi & Co introduced intravenous peramivir in Japan under the name Rapiacta to treat patients with influenza.
Green Cross received marketing and manufacturing authorisation in August 2010 for intravenous peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza.
Image: H1N1 influenza virus. Photo: courtesy of freedigitalphotos.net.