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The U.S. Food and Drug Administration has approved the monoclonal antibody therapies developed by Regeneron for use on patients with Covid-19, including children and the elderly at risk, to help them avoid hospitalization.
The green light for the emergency was given for casirivimab and imdevimab, two monoclonal antibodies developed by Regeneron Pharmaceuticals, to be given to children over the age of 12 and adults, including those over 65 with underlying health conditions, as part of a therapy to stop their condition from worsening.
Justifying the move, the FDA cited clinical trials in coronavirus patients, which indicated that antibodies reduced patients’ hospitalizations and emergency room visits. “At high risk of disease progression” over 28 days after taking the cocktail versus placebo.
The authorization, issued on Saturday, provides that the experimental drug can only be used for treatment “Mild to moderate Covid-19” and is not authorized to be administered in hospital settings.
“Casirivimab and imdevimab are not licensed for patients admitted to hospital due to COVID-19 or in need of oxygen therapy due to COVID-19”, the FDA said, noting that “the safety and efficacy of this experimental therapy … continues to be evaluated.”
Regeneron has become a household name in the US, and it is likely that it will ring a bell even among those unfamiliar with the pharmaceutical industry and the latest advances in researching the latest Covid-19 therapeutic, after it was touted by the president. Donald Trump as a cure for coronavirus.
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‘It was amazing’: Trump recites new anti-Covid-19 ‘cure’ Regeneron, vows it will be FREE for hospital patients
Trump received treatment when he fell ill with Covid-19 in early October thanks to a “Compassionate use” request of his doctors. The president was treated with the antibody drug at Walter Reed Medical Center, after being hospitalized with symptoms of cornavirus as common as reduced oxygen levels and fever.
“It was amazing. I immediately felt good “ Trump said then, fresh out of the hospital, adding that the drug should be free for every coronavirus patient.
His extolling the virtues of Regeneron therapy was received by critics, suggesting he may have had a financial stake in its distribution. Regeneron’s stock went up about 10% after the commander in chief said goodbye to the medicine.
The country’s leading infectious disease expert, Dr. Anthony Fauci, seemed to be pouring cold water on speculation, saying last month it was “A good opportunity” that the cocktail made Trump’s condition “much better.”
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There is a “reasonably good chance” that experimental Regeneron antibody therapy worked for Trump, says Fauci.
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