Eli Lilly’s monoclonal antibody drug reduces the risk of contracting symptomatic COVID-19 among long-term care residents by up to 80%, according to new results from a phase 3 trial. Industry advocates are hailing the news.
Eight weeks after receiving the drug bamlanivimab via infusion, staff and residents had a significantly lower frequency of symptomatic COVID-19 than placebo groups, the drugmaker reported Thursday.
Along with apparently preventing disease, bamlanivimab also showed success as an outpatient treatment for recently diagnosed COVID-19 in skilled nursing and assisted living settings. It significantly reduced the odds of progressing to severe COVID-19 among both residents and staff, supporting earlier trial results that helped lead to federal emergency approval of the drug.
The new results lend evidence to the belief that monoclonal antibodies can reduce symptoms and may even prevent COVID-19, said researcher Myron S. Cohen, M.D., of the federal COVID-19 Prevention Network and an infectious disease expert at the University of North Carolina at Chapel Hill.
“The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devastating impact the virus has had in this vulnerable population and other high-risk patients,” he said.
Industry advocates hail the news — with a caveat
The latest news of the trials, which stand out for their unusual long-term care setting, is reason for optimism, said industry advocates. But it won’t replace the need for COVID-19 vaccination, they said.
“These new data demonstrate that monoclonal antibody therapy is an effective and important weapon in our arsenal to fight COVID-19,” Christopher E. Laxton, CAE, executive director of AMDA, The Society for Post-Acute and Long-Term Care Medicine, told the McKnight’s Clinical Daily. “Keeping the disease from progressing and preventing hospitalizations as we strive for full vaccination of our patient and resident population will lessen the pressure on our overwhelmed hospitals and help keep our nursing home residents safe.”
“This is welcomed news, and we look forward to seeing how this study further develops,” the American Health Care Association/National Center for Assisted Living told the McKnight’s newsletter. “Even so, we encourage every long-term care resident and staff member to get vaccinated.”
Eli Lilly, meanwhile, said it plans to pursue expanded emergency use authorization of bamlanivimab, from a treatment to a preventive drug in skilled nursing facilities and assisted living communities.
The drug should be a shoe-in for receiving further approval, said Kevin W. O’Neil, M.D., chief medical officer of ALG Senior, a senior living provider based in Hickory, N.C.
“This is exciting news from Lilly and the results are very impressive,” said O’Neil, who along with others had originally advised caution in prescribing the drug therapy before more trial data became available. “I am confident this therapy will be fast-tracked to emergency use approval.”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s response to harmful antigens such as viruses. The Food and Drug Administration in November approved bamlanivimab, given by single-dose infusion, for use in non-hospitalized adults and children aged 12 or more years who have mild to moderate COVID-19. The initial goal was to treat high-risk individuals shortly after diagnosis, including adults aged 65 or more years with comorbidities.