An Eli Lilly therapy comprised of two antibodies given together has been awarded FDA emergency authorization for treating Covid-19, providing yet another option for patients diagnosed with the disease.
The decision comes two weeks after Indianapolis-based Lilly reported clinical trial data showing that given together, the antibodies bamlanivimab and etesevimab reduced Covid-19 patients’ risk of hospitalization and death by 70 percent.
The FDA authorization, issued late Tuesday, covers adults and children 12 and older with mild-to-moderate Covid-19 whose cases are at high risk of progressing to severe disease. The authorization also includes patients 65 and older who have certain chronic medical conditions.
The authorization does not include Covid-19 patients who are hospitalized or those who require oxygen therapy to treat the disease. Such patients were not studied in clinical trials. The FDA said that treatment with monoclonal antibodies such as bamlanivimab and etesevimab may be associated with worse outcomes when given to hospitalized patients receiving oxygen treatment or mechanical ventilation.
Bamlanivimab by itself was awarded emergency authorization last November as a treatment for mild-to-moderate Covid-19 in adults and children weighing at least 88 pounds. Etesevimab was developed by Shanghai, China-based Junshi Biosciences. Last year, Lilly and Junshi struck up an alliance to co-develop antibody therapies for Covid-19.
The Lilly and Junshi antibodies are neutralizing antibodies, engineered in a lab to stop a pathogen from causing infection by blocking its ability to bind to enter cells. The antibodies both target the characteristic spike protein on the surface of the novel coronavirus. Each antibody binds to different site on the protein, though those sites overlap, according to the FDA.
The antibody combo treatment was evaluated in a clinical trial enrolling more than 1,000 adults. Those patients, diagnosed with mild-to-moderate Covid-19 symptoms but not hospitalized, were deemed at high risk for progressing to severe Covid-19.
The study dosed 518 patients with a single infusion of the antibody combination while 517 were given a placebo. The main goal was to measure Covid-19 hospitalizations or death, by any cause, after 29 days. In the treatment group, hospitalization occurred in 11 patients, or 2%. No one who received the experimental therapy died. Hospitalization or death occurred in 36 patients, or 7%. The 10 deaths reported in the study were all in the placebo arm.
Lilly reported that the most common side effect from treatment was nausea on the day of the infusion. The results followed encouraging Phase 2 data, which were published in last month in The Journal of the American Medical Association.
The infusion time for these antibodies will be shorter. Lilly said that the FDA authorization reduced the infusion time to 16 minutes for bamlanivimab alone and 21 minutes for the bamlanivimab and etesevimab combination. The Lilly antibody was previously authorized as a 60-minute infusion. Lilly said that the decision to shorten infusion times, made in response to feedback from clinicians who administer the treatments, is intended to reduce the burden on the healthcare system.
Lilly said it will continue to supply bamlanivimab alone under the regulatory authorizations awarded in countries around the world while the company also works to ramp up manufacturing of its antibody cocktail. The company said that under a collaboration with Amgen, it expects it will be able to manufacture up to 1 million doses of the Junshi antibody for use in combination with bamlanivimab by the middle of this year. Lilly added that there are 100,000 doses of the antibody combination ready immediately and an additional 150,000 doses will be available throughout the first quarter.
The combination of bamlanivimab and etesevimab is the second antibody cocktail to secure emergency authorization. Last fall, the FDA authorized a pairing of two antibodies developed by Tarrytown, New York-based Regeneron Pharmaceuticals. That decision covered patients recently diagnosed with mild-to-moderate Covid-19 who are at high risk of progressing to severe disease and hospitalization.
Photo credit: Centers for Disease Control and Prevention