Washington [US], February 10 (ANI): The US Food and Drug Administration (FDA) has granted an emergency use authorization to a monoclonal antibody cocktail made by pharmaceutical company Eli Lilly for treating coronavirus patients at high risk of developing severe COVID-19.
CNN reported that the new treatment adds etesevimab or LY-CoV016 to the already authorized bamlanivimab or LY-CoV555 to make a double-antibody version — one that might be more protective, the company says. Rival Regeneron has a dual antibody-cocktail on the market already.
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. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions, read a statement from the regulating authority.
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.
“In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes,” it added.
This 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, Lilly’s statement read further.
Sputnik citing the FDA reported that a clinical trial showed that a single intravenous infusion of the antibody cocktail “significantly reduced COVID-19-related hospitalization and death” during 29-day follow-up compared to placebo. The regulator continues to evaluate the safety and effectiveness of the therapy
However, according to CNN, Some experiments had indicated that variants of the coronavirus that have developed mutations could evade the effects of Lilly’s single antibody.
“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 percent. 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.
The company further reported that additionally, the outcomes are seen with bamlanivimab and etesevimab together “are consistent” with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone. “The most common adverse event more often reported for patients receiving bamlanivimab and etesevimab together versus placebo was nausea on the day of infusion,” it said further.
The FDA in November granted an emergency use authorization (EUA) for Eli Lilly’s investigational coronavirus antibody treatment called bamlanivimab. (ANI)