US: Eli Lilly's antibody combination gets FDA emergency use authorisation for COVID-19

The US Food and Drug Administration (FDA) on February 10 granted an emergency use authorisation to a monoclonal antibody cocktail made by pharmaceutical company Eli Lilly for treating COVID patients at high risk of developing severe coronavirus. According to CNN, the new treatment adds etesevimab or LY-CoV016 to the already authorised bamlanivimab or LY-CoV555 to make a double-antibody version - one that might be more protective. The authorised use of the new antibody cocktail includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. 

“Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19,” read a statement from the regulating authority. 

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The company said that the bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The pharmaceutical company said that the FDA has also authorised infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively, which is a significant reduction from the previously authorised time of 60 minutes. Eli Lilly added that the decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system. 

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EUA based on Phase 3 data

The FDA has reported that a clinical trial showed that a single intravenous infusion of the antibody cocktail “significantly reduced COVID-19 related hospitalisation and death during 29-day follow-up compared to placebo. The regulator even added that they continue to evaluate the safety and effectiveness of the therapy. Further, the company said that the outcomes are seen with bamlanivimab and etesevimab together are “consistent” with the reduction in risk of hospitalisation or ER visits seen with bamlanivimab alone. 

“The EUA is based on Phase 3 data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 per cent. These data replicate earlier results, published in The Journal of the American Medical Association, in a much larger group of patients," the pharmaceutical company said in a statement.

(With inputs from ANI) 

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