Tags: Coronavirus | Trump Administration | fda | experimental | drug | approval | covid

FDA Grants Emergency Use of Experimental Drug for COVID-19

the fda sign in front of the department campus
The FDA campus. (AP Photo/Andrew Harnik)

By    |   Monday, 09 November 2020 09:42 PM

The Food and Drug Administration on Monday granted doctors emergency authorization to treat high-risk adult and pediatric COVID-19 patients experiencing mild-to-moderate symptoms with an experimental treatment made by Eli Lilly.

Bamlanivimab, a monoclonal antibody therapy, was approved for those who “are at high risk for progressing to severe COVID-19 and/or hospitalization,” the FDA said in a statement on its website.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” the FDA said.

It was approved for patients 12 years and older weighing at least 40 kilograms (about 88 pounds), including those 65 years and older or who have certain chronic medical conditions.

It was not authorized for those already hospitalized for COVID-19 or who require oxygen for treatment of the flu-like respiratory disease.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses, according to the FDA. Bamlanivimab specifically targets the spike protein of SARS-CoV-2 that causes COVID-19, designed to block the virus’ attachment and entry into human cells.

"This emergency authorization allows us to make a COVID-19 treatment available for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," Lilly Chairman and CEO Dave Ricks said in a statement on the company’s website.

The authorization comes nearly two weeks after a study published in the New England Journal of Medicine showed that during a Phase 2 trial bamlanivimab “appeared to accelerate the natural decline in viral load over time.”

The approval came on the same day that Pfizer said the vaccine it has developed to inoculate against the disease has shown to be more than 90% effective and that it will seek regulatory approval by the end of the month.

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The Food and Drug Administration on Monday granted doctors emergency authorization to treat high-risk adult and pediatric COVID-19 patients experiencing mild-to-moderate symptoms with an experimental treatment made by Eli Lilly....
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2020-42-09
Monday, 09 November 2020 09:42 PM
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