BioCryst Pharmaceuticals, Inc. today announced that it has completed its Type C meeting regarding intravenous (i.v.) peramivir with the U.S. Food & Drug Administration (FDA) and has received final meeting minutes.
The minutes of the meeting were consistent with the FDA's preliminary comment letter, which was previously referenced in the Company's press release of April 1, 2013. In addition, the meeting minutes confirmed that BioCryst's proposed peramivir New Drug Application (NDA) content supports a reviewable NDA submission for the indication of acute uncomplicated influenza. In accordance with FDA's recommendation, the Company is in the process of requesting a pre-NDA meeting to reach agreement on a complete NDA submission and to address review issues identified in the minutes.
BioCryst anticipates that The Biomedical Advanced Research and Development Authority (BARDA/HHS) will schedule and hold its In-Process Review (IPR) meeting in the second quarter of this year with the objective of determining the future for the underlying peramivir development contract.
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 pandemic H1N1 swine flu viral strains. Peramivir is being developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous (i.v.) peramivir in Japan under the name RAPIACTAÂ® 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.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and inflammatory diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst currently has two late-stage development programs: peramivir, a viral neuraminidase inhibitor for the treatment of influenza, and ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor for the treatment of gout. In addition, BioCryst has several early-stage programs: BCX4161 and a next generation oral inhibitor of plasma kallikrein for hereditary angioedema and BCX4430, a broad spectrum antiviral for hemorrhagic fevers.