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BARDA-Sponsored Flu Drug Earns FDA Approval

Author: Richard, Hatchett, M.D., BARDA Chief Medical Officer
Published Date: 12/23/2014 11:31:00 AM
Category: Medical Countermeasures; Hospital Preparedness; Innovations;

Our nation achieved a milestone in preparing for pandemic influenza with the FDA approval Friday of Rapivab (peramivir) to treat acute, uncomplicated influenza infection in adults 18 years and older.

Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved in an IV formulation that can be administered in a single dose. This distinction is important for patients who may be unable to swallow pills or inhale a medication.

Neuraminidase inhibitors are commonly used to treat flu infection. These drugs inhibit an enzyme called a neuraminidase, which releases viral particles from infected cells so the virus cannot infect the body’s uninfected cells. This means your body can fight the infection faster and reduces the time and severity of flu symptoms.

Vials of Rapivab (peramivir) approved by FDA to treat influenza.
BARDA has long recognized the need to have antiviral drugs readily available for the treatment of influenza. Each year 5-20 percent of the U.S. population ​develop seasonal flu and could benefit from antiviral treatment. During influenza pandemics, the number of people who become ill can increase rapidly before an influenzavaccine is available and frequently exceeds 25 percent of the total population. Having effective antiviral drugs readily available is a pillar of our preparedness for such public health emergencies.


So beginning in 2007, we awarded a $234.8 million contract to BioCryst in 2007 to develop peramivir for use in pandemic influenza infections. The safety data collected under this development program allowed FDA, during the 2009 H1N1 pandemic, to issue the first Emergency Use Authorization in its history for an unapproved product to treat patients with severe influenza.

The drug becomes the 15th product sponsored by BARDA to earn FDA approval to prevent, diagnose or treat influenza. That’s tremendous progress in less than 10 years. We are proud to have supported development of this influenza therapeutic and so many others to help meet the needs of influenza-infected patients during a public health emergency and every day


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