Covid-19: FDA Issues EUA for Regeneron’s Monoclonal Antibody Tx

Covid-19: FDA Issues EUA for Regeneron’s Monoclonal Antibody Tx

The treatment is a cocktail of two powerful antibodies, Casirivimab and Imdevimab, which must be administered together by intravenous infusion.

WASHINGTON • •The US Food and Drug Administration (FDA) has granted emergency authorisation for the experimental antibody treatment given to President Donald Trump shortly after he was diagnosed with Covid-19, giving doctors another option to treat Covid-19 patients as cases across the United States continue to rise.

It's already reduced COVID-19-related hospitalizations and emergency room visits for patients across the US, including President Trump who was treated with the antibody cocktail after his coronavirus diagnosis. Clinical trials have not shown benefits for using the treatment in hospitalized patients, and in fact, it may lead to worse outcomes for those who need oxygen or ventilation, the FDA says.

The cocktail is authorised for use in Covid-19 positive adults and paediatric patients aged 12 years or above at high risk for advancing to severe Covid-19 and hospitalisation. It is the first COVID-19 combination therapy to receive an EUA from the FDA.

"Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system", Stephen Hahn, MD, commissioner of the FDA, said in a statement.

The treatment is part of a class of drugs known as monoclonal antibodies, which are manufactured copies of antibodies created by the human body to fight infections.

Regeneron is set to have doses ready for 80,000 patients by the end of this month and come January 2021, around 3 lakh patients can be given doses for these.

"Data from approximately 800 non-hospitalized patients showed significant reductions in virus levels within days of receiving REGEN-COV2, which were associated with significantly fewer medical visits".

Pfizer, which has completed its trial, submitted an application last Friday for emergency authorisation of the vaccine, and Moderna said it planned to apply soon.

Regeneron's winning of the FDA's EUA for antibody treatment for Covid-19 is the second, following Eli Lilly's obtaining EUA for its antibody bamlanivimab on November 9.

Casirivimab and imdevimab specifically target the spike protein of SARS-CoV-2 and are created to block the virus's attachment and entry into human cells.

They then harvested the immune cells that made those antibodies and grew them in a lab, in order to create a mass treatment.

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