The US Food and Drug Administration has granted emergency use authorization to a new version of Eli Lilly and Co’s antibody treatment for coronavirus that adds a second monoclonal antibody to one already authorized, the company said Tuesday.
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.
Monoclonal antibodies are lab-engineered versions of highly targeted human antibodies chosen for their specific ability to neutralize, in this case, coronavirus.
"Bamlanivimab and etesevimab, administered together, are authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization,” the FDA said in a statement.
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,” Lilly said in a statement.
“Additionally, the outcomes 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.”