FDA Grants Emergency Authorisation For A 2nd COVID-19 Antibody Treatment


"The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic", Patrizia Cavazzoni, MD, acting director of the FDA's Center for Drug Evaluation and Research, said in a statement.

One of the experimental drugs that US President Donald Trump received while he was battling covid-19, has been approved for emergency use by the Food and Drug Administration.

The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35.

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. "Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with Covid-19 requiring high flow oxygen or mechanical ventilation", the FDA cautioned. It is the first COVID-19 combination therapy to receive an EUA from the FDA.

Hospitalizations and ER visits occurred in 3 percent of patients treated with the combo, versus 9 percent in the placebo-treated group, the FDA said.

Regeneron has said it will have enough of the drug for only about 80,000 people by the end of the month, enough for 200,000 patients by the first week of January, and 300,000 by the end of January.

Djokovic beats Zverev, advances to semifinals at ATP Finals
Djokovic , 33, earned his first break point of the match in the eighth game but Thiem snuffed out the danger. I couldn't return in the important moments, I couldn't make a good shot in the important moments.

The authorised dose under EUA is a single intravenous infusion of 1,200mg of casirivimab plus 1,200mg of imdevimab.

"Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need", he added.

The Trump administration announced plans to distribute on Tuesday 30,000 doses of a newly approved antibody cocktail created to fight mild and moderate cases of COVID-19.

They work by binding to a surface protein of the SARS-CoV-2 virus and stopping it from invading human cells.

The EUA is, however, a different approval, as the FDA warns that it has concluded that the "potential benefits of these antibodies outweigh the known and potential risks".

The New York Times said REGN-COV2 has shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease.