FDA Authorizes Second Eli Lilly Monoclonal Antibody to Treat COVID-19

The Food and Drug Administration (FDA) has authorized a second monoclonal antibody therapy to treat patients with COVID-19. The agency granted an emergency use authorization (EUA) to the drugs bamlanivimab and etesevimab used together for the treatment of mild to moderate COVID-19 in individuals aged 12 and older, who are at high risk of developing severe COVID-19.

A clinical trial found that a single IV infusion of bamlanivimab and etesevimab “significantly reduced” the risk of hospitalization and death from COVID-19 during 29 days of follow-up compared to a placebo in patients with the virus who were at a high risk of progressing to severe disease.

The trial enrolled 1,035 non-hospitalized adults with mild to moderate COVID-19 symptoms who were at high risk for progressing to severe COVID-19 and either gave them a single infusion of 2,800 milligrams of bamlanivimab and etesevimab or a placebo. Researchers found that 36 patients (7%) who received the placebo were hospitalized or died, compared to 11 (2%) who were treated with the combination therapy, marking a 70% reduction. There were 10 deaths, and all were patients in the placebo group.

This isn’t the first monoclonal antibody treatment authorized for use by the FDA. The agency granted an EUA to bamlanivimab alone in November.

Bamlanivimab “was shown to be effective in reducing hospitalization rates among patients at high risk for disease progression if used early in the disease,” Sunanda Gaur, MD, director of the Clinical Research Center at the Rutgers Robert Wood Johnson Medical School in New Jersey, tells Verywell.

Gaur says the results from the trial are “promising” but points out that the full data isn’t available yet. Still, she says, this combination is “potentially more effective than bamlanivimab given alone.” 

How Does It Work?

Bamlanivimab is a monoclonal antibody therapy, which works by binding directly to portions of viruses to help keep them from infecting a person. Bamlanivimab targets the spike protein of SARS-CoV-2, the virus that causes COVID-19. It’s designed to block the virus’s ability to attach and enter human cells. The treatment is delivered through an IV.

Etesevimab is also a monoclonal antibody that binds to the surface of the SARS-CoV-2 spike protein receptor. Etesevimab works similarly to bamlanivimab and was created by the same company, Eli Lilly.

Not everyone is eligible for this treatment. The FDA states that only people aged 12 and older, who are deemed to be at high risk for severe complications of the virus, can receive the treatment.

Bamlanivimab and etesevimab are not authorized for patients who are hospitalized or require oxygen therapy due to COVID-19. Monoclonal antibodies like bamlanivimab and etesevimab can cause worse outcomes in these patients, particularly in those that require high flow oxygen or mechanical ventilation.

Mixed Feelings

While doctors applaud the news, several point out that many in the field haven’t been using monoclonal antibodies. “Some had been waiting for additional evidence regarding the efficacy of these agents in larger clinical trials,” Prathit Kulkarni, MD, assistant professor of medicine in infectious diseases at Baylor College of Medicine in Texas, tells Verywell.

As a result, “there is a general lack of knowledge about monoclonal antibodies in the medical community,” Richard Watkins, MD, an infectious disease physician and professor of internal medicine at the Northeast Ohio Medical University, tells Verywell. And, he adds, “a lot of patients have never heard of them.”

The treatment itself is also more complicated than just prescribing someone a pill, Watkins says, noting that “there are staffing issues in terms of giving the infusions in outpatient settings.”  

Gaur agrees. “It is logistically difficult to administer since it requires infusion which can take several hours,” she says. “More robust data on the benefit of this approach of early treatment will be needed to convince doctors.”

Overall, though, Watkins says the authorization is promising. “I am glad physicians will now have another therapy to fight COVID-19,” he says.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.