The emergency green light was given for casirivimab and imdevimab, two monoclonal antibodies developed by Regeneron Pharmaceuticals, to be administered to children above 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 of coronavirus patients, which indicated the antibodies reduced hospitalizations and ER visits from patients “at high risk for disease progression” within the span of 28 days after they took the cocktail as compared to placebo.
The FDA has issued an Emergency Use Authorization for our investigational antibody cocktail to treat mild to moderate #COVID19 in certain high-risk patients 12 years and older. Learn more: https://t.co/yNfOFPyLI0 pic.twitter.com/0QGBnddiVC
— Regeneron (@Regeneron) November 22, 2020
The authorization, issued on Saturday, stipulates that the experimental drug can be used only to treat “mild to moderate Covid-19” and is not cleared to be administered in hospital settings.
“Casirivimab and imdevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19,” the FDA said, noting that “the safety and effectiveness of this investigational therapy… continues to be evaluated.”
Regeneron became a household name in the US, and is likely to ring a bell even among those not familiar with the pharmaceutical industry and the latest progress in searching for the ultimate Covid-19 therapeutic, after it was touted by US President Donald Trump as a coronavirus cure.
Trump was given the treatment when he fell sick with Covid-19 in early October thanks to a “compassionate use” request from his doctors. The president was treated with the antibody drug at Walter Reed Medical Center, after he was hospitalized with such common cornoavirus symptoms as reduced oxygen levels and a fever.
“It was, like, unbelievable. I felt good immediately,” Trump said back then, fresh out of the hospital, adding that the drug should be free for every coronavirus patient.
Him extolling the virtues of Regeneron therapy was met with backlash from critics, suggesting that he might have had a financial interest in its distribution. Regeneron’s stock jumped some 10 percent after the commander-in-chief hailed the medicine.
Country’s top infectious diseases expert, Dr. Anthony Fauci, appeared to pour cold water on the speculations, saying last month that it was “a reasonably good chance” that the cocktail made Trump’s condition “much better.”
Think your friends would be interested? Share this story!