BARDA's Influenza Therapeutics Program strategy, as defined in The National Strategy for Pandemic Influenza Implementation Plan (2006) (PDF - 404 MB), is to develop and stockpile therapeutics that reduce morbidity and mortality from influenza infection. A primary goal of the program is to establish national stockpiles of FDA-approved antivirals to ensure treatment of influenza-infected persons during an influenza pandemic. Maintenance of this antiviral stockpile allows potentially life-saving treatment of millions of people, including pediatric populations, during an influenza pandemic. An equally important goal of the program is to support advanced development of new antiviral and immunotherapeutic candidates towards FDA approval to address the critical need for new classes of antivirals and immunotherapeutics, and for treatment options that can be used later in the course of infection to treat severely ill, influenza infected patients who are hospitalized.
In 2009, BARDA, in cooperation with CDC, met the National Strategy goal of stockpiling 81 million treatment courses of influenza antivirals in state and federal stockpiles, including 17 million treatment courses for pediatric populations. BARDA provided subsidies to States and contracting mechanisms to procure influenza antiviral drugs for their stockpiles. Portions of these assets were deployed to the States during the 2009 H1N1 pandemic; the federal stockpiles were subsequently replenished and maintained at the requirement level. CDC maintain influenza therapeutic stockpiles, and BARDA continues to lead advanced development of novel therapeutics to address unmet needs, especially those of severely ill, hospitalized, and pediatric populations.
The Influenza Therapeutics Program has funded six novel antiviral advanced development projects since 2007. One of the earliest projects supported development of intravenous (IV) peramivir, which received Emergency Use Authorization during the 2009 H1N1 pandemic. This product (Rapivab®) recently received FDA approval in 2014 as a single-dose influenza antiviral drug for treatment of uncomplicated influenza. In 2015, BARDA awarded contracts to support two new novel influenza therapeutics that have novel mechanisms of action compared to existing approved antivirals.
Rapid emergence of novel influenza strains with resistance to available antiviral agents, lack of approved treatment options for hospitalized and other “at risk” populations, and the lack of universally-validated clinical endpoints for severe cases of influenza leads the Influenza Therapeutics Program to seek immunotherapeutic candidates for treatment of influenza. The program continues to support advanced development of novel antiviral agent candidates but also includes monoclonal antibodies that neutralize influenza virus by binding to the hemagglutinin stalk region. The Program also supports candidates that prevent transcription or replication of viral genomes by inhibiting viral polymerase or other viral activities and that modulate the immune response by affecting host factors. Novel antiviral drugs, especially when used in conjunction with early identification through diagnostics, can strengthen preparedness and response levels by enabling public health professionals to effectively treat influenza disease in patients, and thereby potentially limit the spread of disease in communities.