FDA issues emergency use authorization for Eli Lilly COVID-19 antibody drug

The Food and Drug Administration (FDA) issued an emergency use authorization on Monday for an Eli Lilly antibody drug to treat mild to moderate cases of COVID-19.

The FDA’s authorization of bamlanivimab will permit the federal government to distribute the drug to state and territorial health departments to give to certain facilities. The U.S. already committed last month to 300,000 doses of the experimental drug, paying Eli Lilly $375 million.

People who are 12 years or older, weigh at least 40 kilograms and are at high risk of developing severe COVID-19 and/or hospitalization will be allowed to take the drug under the authorization. Those at high risk include people 65 years or older and those who have preexisting health conditions.

COVID-19 patients who are hospitalized for the virus or need oxygen therapy will not be permitted to take the drug. 

Eli Lilly said in a release that bamlanivimab should be given to patients “as soon as possible” after a positive COVID-19 test and within 10 days of the start of symptoms.

Michael Bars, a White House spokesman, said in a statement that the authorization is “a major milestone,” noting patients will be able to receive the drug without out-of-pocket costs.

“Through continued determination, this treatment and others like it will help protect the health and well-being of millions of vulnerable Americans until a safe and effective vaccine is approved for use,” he said. 

The emergency use authorization allows bamlanivimab to be distributed while the FDA continues to research its safety and effectiveness. It comes after clinical trials determined the drug might help decrease hospitalization or emergency room visits for high-risk patients. 

In the trial of 465 nonhospitalized adults with mild to moderate COVID-19 symptoms, hospitalizations and emergency room visits occurred in 3 percent of patients treated with the drug, compared to 10 percent of those treated with the placebo.

The company expects to make up to 1 million doses of the drug before the end of 2020 to be used through early 2021. The company expects to “increase substantially” its production next year.

Eli Lilly’s deal with the U.S. government came after federal researchers determined the drug had little clinical benefit for hospitalized COVID-19 patients. But the company said its drug will assist those earlier in the COVID-19 infection process.

The FDA’s emergency approval comes as the U.S. is facing a surge of coronavirus cases, with The New York Times measuring the seven-day average of new cases per day reaching 111,175 new cases.

—Updated at 8:47 p.m.