TUESDAY, JUNE 19, 2018

HHS unit sponsoring development of drug for severe flu cases

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is sponsoring a drug being developed to treat patients hospitalized with severe cases of influenza. the Biomedical Advanced Research and Development Authority (BARDA) said this week.

The drug still needs approval from the U.S. Food and Drug Administration (FDA), but  once approved, it would be the first drug specifically for patients hospitalized with influenza and the first in a new class of influenza antivirals.

BARDA, which operates under the ASPR, will provide technical assistance and funding to Janssen Pharmaceuticals, a Johnson & Johnson subsidiary that specializes in advanced drug development. Studies on the drug, referred to as JNJ-872, show that it may provide clinical benefits even if administered after the first 48 hours of symptoms. Most influenza drugs must be given within that 48-hour window to be beneficial.

“Typically, patients are not hospitalized within 48 hours of developing flu symptoms, so doctors and their patients need treatment options that are effective later in the course of the illness,” BARDA Director Robin Robinson said. “This is a critical health priority as tens of thousands of flu patients are hospitalized each year in the United States, and that number can be even higher in a pandemic.”

BARDA’s involvement is part of a goal to develop a product that can also treat patients who may be at higher risk of getting the influenza virus, such as those with compromised immune systems.

“We’re interested in manufacturing innovation as part of medical countermeasure development to be as agile, efficient and cost-effective as possible, and continuous manufacturing has that potential,” Robinson said.


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U.S. Department of Health and Human Services U.S. Food and Drug Administration (FDA)

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