FDA Authorizes Eli Lilly's Bamlanivimab for Early-Stage COVID-19 Treatment
Key Insights
The FDA granted emergency use authorization (EUA) to Eli Lilly's bamlanivimab (LY-CoV555) for treating mild-to-moderate COVID-19 (search) in adults and pediatric patients.
Bamlanivimab, a monoclonal antibody, is authorized for patients with positive SARS-CoV-2 test results who are at high risk of progressing to severe COVID-19 (search) or hospitalization.
The drug should be administered as soon as possible after a positive COVID-19 (search) test and within 10 days of symptom onset, according to Eli Lilly.
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Eli Lilly's bamlanivimab, a monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19 (search) in adult and pediatric patients. This authorization marks a significant step forward in the outpatient treatment of COVID-19, offering a potential means to prevent disease progression and hospitalization in high-risk individuals.
Bamlanivimab: Mechanism and Indication
Bamlanivimab (LY-CoV555) is a monoclonal antibody designed to block the SARS-CoV-2 virus from attaching and entering human cells, thereby neutralizing the virus. The EUA specifies that bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older, weighing at least 40 kilograms (approximately 88 pounds), and who are at high risk for progressing to severe COVID-19 (search) and/or hospitalization. This includes individuals 65 years of age or older or those with certain chronic medical conditions.
Eli Lilly recommends that bamlanivimab be administered as soon as possible after a positive COVID-19 (search) test and within 10 days of symptom onset. The drug is administered intravenously as a single dose of 700mg.
Clinical Trial Data
Data from the Phase 2 stage of Eli Lilly's Blaze-1 trial demonstrated that bamlanivimab helped prevent complications that would have required hospitalization. This finding supported the FDA's decision to grant the EUA. However, it's important to note that another Eli Lilly study was stopped due to a lack of efficacy in patients with severe COVID-19 (search).
Limitations and Considerations
The FDA has clearly stated that bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 (search) or require oxygen therapy due to COVID-19. Furthermore, the agency warns that monoclonal antibodies like bamlanivimab may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Broader Context
The EUA for bamlanivimab arrives amidst ongoing efforts to develop effective treatments for COVID-19 (search). Other companies, such as Regeneron, are also developing monoclonal antibody therapies. The emerging consensus is that neutralizing antibodies are most effective when administered early in the course of the infection. This underscores the importance of rapid and widespread COVID-19 testing to identify eligible patients promptly.
Potential Side Effects
The FDA notes that possible side effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.