Regeneron COVID-19 therapy, given to Trump, gets emergency use authorisation from US FDA

While the world continues to battle the COVID-19 pandemic, US drug regulator on November 21 gave emergency approval to Regeneron Pharmaceutical Inc.’s coronavirus antibody therapy. According to the official website, this treatment consisted of two monoclonal antibodies that target the spike protein used by the virus to enter cells. Back in October, US President Donald Trump was treated with the drug based on a compassionate-use request by his doctors. 

In a statement, the US FDA said, “In a clinical trial of patients with Covid-19, casirivimab and imdevimab, administered together, were shown 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 safety and effectiveness of this investigational therapy for use in the treatment of Covid-19 continues to be evaluated,” the statement read. 

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The trial finding released by Regeneron had shown that the drug may help treat patients outside the hospital, reducing virus levels and the need for further medical care. The earlier results had pushed Regeneron executives to reach out to the US Food and Drug Administration about pursuing emergency-use authorisation. The agency informed that the casirivimab and imdevimab are not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy, but it may be associated with worse clinical outcomes when administered to hospitalised patients with coronavirus requiring high flow oxygen or mechanical ventilation. 

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‘FDA committed to advancing public health’ 

“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” said FDA Commissioner Stephen M. Hahn, M.D.

The agency informed that the issuance of a EUA is different than FDA approval. According to the official website, in determining whether to issue a EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Further, the FDA said that they have determined that it is reasonable to believe that casirivimab and imdevimab administered together may be effective in treating patients with mild or moderate COVID-19. 

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