The US Food and Drug Administration (FDA) has accepted to review for the BioCryst Pharmaceuticals‘ New Drug Application (NDA) for intravenous (i.v.) peramivir that was submitted to the agency in December 2013. The FDA assigned the NDA a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014.
The FDA has informed BioCryst that at this time, it does not plan to hold an Advisory Committee review of the NDA.
“We are pleased that BioCryst’s first NDA filing has been accepted by the FDA. 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,” said Jon P Stonehouse, president & chief executive officer. “BioCryst is preparing to make peramivir available in the US during the 2014-15 influenza season, provided approval is granted within that timeframe.”
In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission included results in over 2,700 subjects treated with peramivir in 27 clinical trials. Peramivir has been approved in Japan and Korea. It is estimated that more than one million patients have received peramivir treatment to date.
Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. Peramivir has been developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza.
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians.