Monoclonal Antibodies for Treatment of COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19.

In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo.

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Authorized Use

The FDA permit the emergency use of bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.

Who are at higher risk for progression to severe COVID-19?

The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19:

• Older age (for example age ≥65 years of age)

• Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on growth charts)

• Pregnancy

• Chronic kidney disease

• Diabetes

• Immunosuppressive disease or immunosuppressive treatment

• Cardiovascular disease (including congenital heart disease) or hypertension

• Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)

• Sickle cell disease

• Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)

• Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)).

Note: Healthcare providers should consider the benefit-risk for an individual patient. Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies.

When & How bamlanivimab and etesevimab be administered?

It is recommended that bamlanivimab and etesevimab be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Bamlanivimab (700 mg) and etesevimab (1,400 mg) are administered together as a single intravenous infusion.

Dosage & Administration

The authorized dosage is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous (IV) infusion as soon as possible after positive viral test for SARS-CoV-2 and within ten days of symptom onset

Note: Bamlanivimab and etesevimab may only be administered in settings in which health care providers 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.

Are there limitations of the authorized use under this EUA?

Yes.

Bamlanivimab and etesevimab administered together are not authorized for use in patients:

• who are hospitalized due to COVID-19, or

• who require oxygen therapy due to COVID-19, or

• who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Note: Treatment with bamlanivimab and etesevimab, administered together, has not been shown to provide benefit in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.