The Food and Drug Administration (FDA) on Monday declared an emergency authorization of monoclonal antibody therapy from pharmaceutical company Eli Lilly
to treat patients with mild to moderate symptoms of COVID-19
.
Trials of Eli Lilly's bamlanivimab drug given together with the antiviral drug remdesivir in hospitalized patients were discontinued at the end of October after federal investigators concluded that this drug combination did not produce an improvement in the target population.
How is the new authorization different from canceled tests?
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Now, the use of the monoclonal antibody bamlanivimab has received an emergency clearance from the FDA for patients 12 years and older who are at increased risk of requiring hospitalization.
Unlike the tests canceled in October, this time bamlanivimab will not be given along with remdesivir
nor will it be used for patients already hospitalized
.
This photograph provided by Eli Lilly Laboratories shows the drug Bamlanivimab, approved on Monday, November 9, 2020 by the United States Food and Drug Administration for emergency use against COVID-19.
“While the safety and efficacy of this investigational therapy continues to be evaluated, bamlanivimab has been shown in clinical studies to reduce hospitalizations or visits to the emergency room in patients at high risk of disease progression, in a range of 28 days after treatment, compared to using a placebo, "the federal agency said in a press release.
The treatment is similar to that received by the president, Donald Trump, when he fell ill with coronavirus in early October, with the exception that the president also received other medications such as remdesivir.
Former New Jersey Governor Chris Christie also underwent bamlanivimab therapy when he became infected with the virus.
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The government reached an agreement in October to buy and supply much of Eli Lilly's initial production of the drug
.
Only one drug, Gilead Sciences' remdesivir, has full FDA approval as a treatment for COVID-19.
Government guidelines also support the use of dexamethasone and other steroids for certain seriously ill hospitalized patients.
Another treatment now has an emergency use designation: convalescent plasma or blood from COVID-19 survivors.
However, no large enough study has shown it to be more effective than usual care alone.
The new drug is part of an emerging family of biologic therapies that offer a promising new approach to preventing serious illness and death from COVID-19.
Experts say the infused drugs could serve as
a therapeutic bridge to help control the virus until vaccines are widely available
.
With information from The Associated Press
.