The drug is being evaluated as part of a Phase 3 trial involving 965 participants that was conducted in part by the National Institute of Allergy and Infectious Diseases and the COVID-19 Prevention Network.
The monoclonal antibody therapy, called bamlanivimab, is currently approved by the FDA for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients who are 12 years of age and older and are at high risk for progressing to severe COVID-19 and or hospitalization. The FDA said this includes patients who are 65 years of age or older or who have certain chronic medical conditions.
At the time of authorization, the FDA said the drug had been found to reduce COVID-19 related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment. It was not authorized for patients hospitalized due to COVID-19 or those requiring oxygen due to the virus. There was no benefit shown in patients hospitalized due to the virus.
In the latest study, according to a news release posted by Eli Lilly, at eight weeks follow-up there was a “significantly lower frequency of symptomatic COVID-19” in the participants who received bamlanivimab versus those who received the placebo.
In a subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those who received the drug versus the placebo.
Four participants who were in the placebo group died due to COVID-19 during the trial period.
The company said results reflected up to an 80% lower risk of contracting the virus.
"We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said in a news release.
"These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic," he continued. "We're glad bamlanivimab is already available as a treatment for patients at high risk for progressing to severe COVID-19 illness or hospitalization, including those in nursing homes, and look forward to working with regulators to explore expanding the emergency use authorization to prevent the spread of COVID-19 in these facilities."