Overview
Etesevimab (LY-CoV016, also known as JS016) is a fully human and recombinant monoclonal antibody that targets the SARS-CoV-2 surface spike protein receptor binding domain. Under the EUA granted in February 2021, etesevimab is used in combination with bamlanivimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19: this EUA later expanded in December 2021 to include all younger children at high risk, including newborns. The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.
Background
Etesevimab (LY-CoV016, also known as JS016) is a fully human and recombinant monoclonal antibody that targets the SARS-CoV-2 surface spike protein receptor binding domain. Under the EUA granted in February 2021, etesevimab is used in combination with bamlanivimab to treat mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19: this EUA later expanded in December 2021 to include all younger children at high risk, including newborns. The EUA currently allows bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19 in adults and children.
Indication
Etesevimab in combination with bamlanivimab is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This combination regimen is also used for post-exposure prophylaxis of COVID-19 in unvaccinated or immunocompromised adults and pediatric individuals, including neonates, who are at high risk of progression to severe COVID-19, including hospitalization or death.
Associated Conditions
- Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/06/18 | Phase 2 | UNKNOWN | |||
2020/11/18 | Phase 2 | Completed | |||
2020/11/02 | Phase 1 | Completed | |||
2020/08/04 | Phase 3 | Completed | |||
2020/06/22 | Phase 1 | Completed | |||
2020/06/11 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Eli Lilly and Company | 0002-7950 | INTRAVENOUS | 35 mg in 1 mL | 8/11/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||