Feds halt distribution of Eli Lilly’s bamlanivimab alone for COVID-19
The U.S. government, in collaboration with Eli Lilly, said it has halted the distribution of the drug maker’s monoclonal antibody bamlanivimab alone to treat COVID-19 because of concerns about emerging SARS-CoV-2 variants.
HHS announced the update online, saying the government stopped distributing the therapy alone on March 24 due to a “sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants.”
In an update to its Fact Sheet for Healthcare Providers regarding bamlanivimab, the FDA said using other monoclonal antibody therapies that are more likely to retain activity against the variants may reduce the possibility of treatment failure from an infection that is resistant to bamlanivimab alone.
The FDA also noted that bamlanivumab is not authorized for the following patients:
- patients hospitalized due to COVID-19;
- patients with COVID-19 requiring oxygen therapy; and
- patients requiring increased baseline oxygen flow rate due to COVID-19 in individuals with chronic oxygen therapy caused by an underlying comorbidity.
The FDA issued an emergency use authorization for bamlanivimab in November for mild to moderate COVID-19 in adults and children.
The Infectious Disease Society of America suggests using bamlanivimab together with the monoclonal antibody etesevimab for outpatients with mild to moderate COVID-19 who are at a high risk for severe disease progression. During an IDSA briefing last week, Rajesh T. Gandhi, MD, a member of the IDSA’s expert panel on COVID-19 treatment and management guidelines and an infectious diseases physician at Massachusetts General Hospital, noted that data are limited on the use of bamlanivimab alone for the treatment of COVID-19.
HHS said treatment delivery sites would continue to be able to order bamlanivimab and etesevimab to be administered together.
FDA. Fact sheet for health care providers: emergency use authorization of bamlanivimab. https://www.fda.gov/media/143603/download. Accessed March 26, 2021.