- Bamlanivimab received an emergency use authorization (EuA)by the FDA for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.
- Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing
- Are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and
- Are at high risk for progressing to severe COVID-19 and/or hospitalization including those that are 65 years of age or older, or who have certain chronic medical conditions.
Bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Contra-indications and or cautions
- Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
- A benefit of bamlanivimab treatment has not been shown in patients hospitalized due to COVID-19.
- Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.
Data and clinical studies
- The data supporting this EUA for bamlanivimab are based on an interim analysis from a phase two randomized, double-blind, placebo-controlled clinical trial in 465 non-hospitalized adults with mild to moderate COVID-19 symptoms.
- Of these patients, 101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS-CoV-2 viral test.
- The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo.
- Most patients, including those receiving placebo, cleared the virus by day 11.
- The most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment.
- For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients.
- The effects on viral load and on reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses.
When to start
It is recommended that bamlanivimab be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.
- Bamlanivimab is administered as a single dose of 700 mg via IV infusion over 60 minutes.
- Bamlanivimab may only be administered in settings in which health care providers would have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS) as necessary.
- Please note that bamlanivimab approved by the FDA to treat COVID-19 and it is an investigational drug.
- It is not currently FDA-approved to treat any diseases or conditions, including COVID-19.
- With the EUA, amlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bamlanivimab is manufactured by Eli Lilly and Company.