The late-stage study is looking at whether Lilly’s antibody, known as bamlanivimab, could help hospital patients. The treatment is a monoclonal antibody that mimics the antibodies the body makes naturally. It is similar to the Regeneron antibody cocktail that President Donald Trump recently received after he was diagnosed with Covid-19.
background: Last week, Lilly asked the FDA to issue an emergency clearance that would allow the antibody treatment to be used in high-risk patients recently diagnosed with mild to moderate Covid-19.
This application is largely based on preliminary data from a Phase II study published in mid-September, which found that patients who received a dose of the antibody were less likely to be hospitalized or to visit the emergency room.
What’s next: The data and safety oversight body overseeing the study will try to better understand what caused the safety concerns and whether or not to restart the study.