Overview of Monoclonal Antibody Treatment for COVID-19 Made Available Under Emergency Use Authorization
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses and bacteria which can cause disease. Currently there are two monoclonal antibody therapies approved for use under an Emergency Use Authorization.
On November 9, 2020, Eli Lilly and Company received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody treatment bamlanivimab. The EUA allows healthcare providers to administer bamlanivimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. In alignment with the terms of the EUA for bamlanivimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of this treatment and coordinate its distribution.
Bamlanivimab plus Etesevimab
Eli Lilly and Company received EUA on February 9, 2021 from the FDA for the use of bamlanivimab and etesevimab administered together to non-hospitalized patients with confirmed COVID-19 who are experiencing mild-to-moderate symptoms and are at high risk for severe disease and hospitalization. While bamlanivimab may currently be administered alone under a separate EUA, etesevimab is not authorized for use alone and must be administered with bamlanivimab. The two drugs, administered together, were shown to reduce COVID-19-related hospitalization or emergency department visits in patients at high risk for disease progression.
On November 21, 2020, Regeneron Pharmaceuticals, Inc. received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational treatment cocktail consisting of 2 monoclonal antibodies, casirivimab and imdevimab. The EUA allows healthcare providers to administer casirivimab/imdevimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. In alignment with the terms of the EUA for casirivimab/imdevimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of this therapeutic and coordinate its distribution.
Allocation and Distribution Process
The Illinois Department of Public Health is committed to the equitable and efficient distribution of monoclonal antibody therapy treatments throughout Illinois, no matter the location and regardless of income. IDPH is committed to distributing these therapies quickly in partnership with AmeriSource Bergen, the distributor of the therapeutics.
Allocations to the state/territory’s are based on the total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients during a seven-day reporting period will equal that state/territory’s percentage of available monoclonal antibody therapy for a given distribution week.
Individuals Seeking Treatment
Individuals who have tested positive and are experiencing mild or moderate COVID-19 illness and symptoms and are considered “high risk” for progressing to severe COVID-19. Pediatric patients, 12 years of age or older weighing at least 40 kilograms (about 80 pounds), and adults included those 65 years of age or older with certain chronic medical conditions can be considered eligible to receive this treatment. Chronic medical conditions include, but are not limited to:
- Having a body mass index (BMI) greater than 35
- Chronic kidney disease
- Immunosuppressive disease
- Are currently receiving immunosuppressive treatment
Individuals who meet high risk criteria and test positive should contact their primary care physician about a referral for antibody treatment within three days of a positive test result and no later than 10 days after symptom onset.
Treatment for COVID-19 is limited at this time. Check with your health care provider about the use of monoclonal antibodies (bamlanivimab or casirivimab/imdevimab) or an antiviral (remdesiver).