The US Food and Drug Administration has approved regenerative monoclonal antibody therapies to be used in patients with Covid-19, including children and the elderly at risk, to help them avoid hospitalization.
Emergency green light was given to casirivimab and imdevimab, two monoclonal antibodies developed by Regeneron Pharmaceuticals, to be administered to children over 12 years of age and adults, including those over 65 years of age with basic health conditions, as part of therapy to stop their condition from deteriorating.
Justifying the move, the FDA cited clinical trials of coronavirus patients, indicating reduced antibody hospitalization and ER visits by patients “At high risk for disease progression” within 28 days of taking the cocktail compared to placebo.
The authorization, issued on Saturday, stipulates that the experimental drug be used for treatment only “Mild to moderate Covid-19” and is not allowed to be administered in a hospital setting.
“Casirivimab and imdevimab are not authorized for patients hospitalized due to KOVID-19 or in need of oxygen therapy due to KOVID-19.” said the FDA, noting that “The safety and effectiveness of this investigative therapy … continues to be assessed.”
Regeneron has become a household name in the United States and is likely to resonate with those unfamiliar with the pharmaceutical industry and the latest advances in the search for the ultimate therapeutic Covid-19 after it was advertised by US President Donald Trump as a coronavirus drug.
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Trump was given treatment when he fell ill with Covid-19 in early October thanks to a “Compassionate use” asked his doctors. The president was treated with an antibody drug at Walter Reed Medical Center after being hospitalized with such common symptoms of cornavirus as low oxygen levels and fever.
“It was amazing. I felt good right away “ Trump then said, fresh out of the hospital, adding that the drug should be free for every coronavirus patient.
Praising the virtues of Regeneron therapy, he met with a backlash from critics, suggesting that he may have had a financial interest in distributing it. Shares of Regeneron jumped about 10 percent after the commander-in-chief welcomed the drug.
The country’s top infectious disease expert, Dr Anthony Fauci, appeared to pour cold water on speculation, saying last month that it was “Reasonably good chance” that the cocktail made Trump’s condition “very better.”
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“There is a ‘reasonably good chance’ experimental Regeneron antibody therapy worked for Trump,” Fauci said.
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