Drug updated on 9/5/2024
| Dosage Form | Injection (intravenous; 600 mg) |
| Drug Class | Recombinant human monoclonal antibodies (mAbs) |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients (12 years of age and older weighing at least 40 kg) 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.
Latest News
Summary
- REGEN-COV (casirivimab and imdevimab) is indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult and pediatric patients (12 years of age and older, weighing at least 40 kg) 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 summary is based on the review of 14 systematic review(s)/meta-analysis(es). [1-14]
- Casirivimab/Imdevimab (CAS/IMD) reduced mortality in COVID-19 patients (OR = 0.62; 95% CI: 0.40-0.98), significant in baseline seronegative patients (OR 0.67; 95% CI: 0.50-0.91).
- CAS/IMD reduced hospitalization rates (OR = 0.86; 95% CI: 0.79-0.93); Bamlanivimab/Etesevimab (BAM/ETE) also reduced hospitalizations in non-hospitalized patients (OR: 0.37; 95% CI: 0.29-0.49). Sotrovimab was the most effective in reducing hospitalizations (OR 0.20; 95% CI: 0.08-0.48).
- CAS/IMD reduced the progression of clinical symptoms (OR = 0.86; 95% CI: 0.79-0.93); BAM/ETE reduced disease progression to severe degrees (RR = 0.778; 95% CI: 0.550-1.099).
- CAS/IMD improved viral load clearance, increased hospital discharge rates, and reduced cesarean sections in pregnant women (RR = 0.665; 95% CI: 0.491-0.899).
- Casirivimab/Imdevimab (CAS/IMD): Slight decrease in the likelihood of adverse events; potential slight increase in all-grade adverse events (RR 1.14, 95% CI 0.98 to 1.31); no increase in serious adverse events compared to placebo.
- Bamlanivimab/Etesevimab (BAM/ETE): Adverse events generally uncommon and tolerable; possible increase in serious adverse events (RR 1.40, 95% CI 0.45 to 4.37); no significant increase in adverse effects observed across various studies.
- Other mAbs: Convalescent plasma and anti-COVID IVIg associated with increased adverse events; infusion-related reactions common among various mAbs, with some showing better safety profiles (e.g., sotrovimab).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| REGEN-COV (casirivimab and imdevimab) Prescribing Information. | 2022 | Regeneron Pharmaceuticals, Inc., Tarrytown, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| COVID-19 treatments approved in the European Union and clinical recommendations for the management of non-hospitalized and hospitalized patients. | 2022 | Annals of Medicine |
| Japanese rapid/living recommendations on drug management for COVID-19: updated guidelines (July 2022). | 2022 | Acute Medicine & Surgery |
| Care for adults with COVID-19: living guidelines from the National COVID-19 Clinical Evidence Taskforce. | 2022 | Medical Journal of Australia |
| Updated guidance on use and prioritization of monoclonal antibody therapy for treatment of COVID-19 in adolescents. | 2022 | Journal of the Pediatric Infectious Diseases Society |
| ESCMID COVID-19 living guidelines: drug treatment and clinical management. | 2022 | Clinical Microbiology and Infection |
| Recommendations on the in-hospital treatment of patients with COVID-19. | 2021 | Deutsches Ärzteblatt International |