Drug updated on 12/11/2024
| 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
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- Mortality Reduction: Casirivimab/imdevimab significantly reduced mortality in COVID-19 patients (odds ratio (OR) = 0.62; 95% confidence interval (CI) = 0.40-0.98), with higher effectiveness observed in seronegative individuals (OR = 0.67, 95% CI 0.50-0.91). Bamlanivimab/etesevimab also decreased mortality (OR = 0.13, 95% CI = 0.02-0.77), though casirivimab/imdevimab showed greater effectiveness in baseline seronegative patients.
- Progression of Clinical Symptoms: Casirivimab/imdevimab reduced the progression of clinical symptoms in COVID-19 patients (OR = 0.86; 95% CI = 0.79-0.93). Other treatments, such as remdesivir and IFN-alpha 2b, did not prevent disease progression in pregnant patients.
- Hospitalization and Post-Exposure Prophylaxis: In non-hospitalized patients, casirivimab/imdevimab reduced the risk of hospitalization (OR = 0.43, 95% CI = 0.08-2.19) and, in post-exposure settings, significantly decreased SARS-CoV-2 infection (relative risk (RR) = 0.34, 95% CI = 0.23-0.48) and the development of clinical symptoms (RR = 0.19, 95% CI = 0.10-0.35). Other monoclonal antibodies like bamlanivimab and sotrovimab similarly reduced hospitalizations but with varied certainty.
- Viral Load and Discharge Rates: Casirivimab/imdevimab improved viral load clearance and increased discharge rates in hospitalized COVID-19 patients.
- General Safety Profile: Casirivimab/imdevimab (Regen-Cov) showed a slight increase in all-grade adverse events (AEs) (RR 1.14; 95% CI 0.98 to 1.31) but had no significant impact on serious adverse events (SAEs). Bamlanivimab also exhibited increased all-grade AEs, though with low certainty, while sotrovimab was associated with a reduction in SAEs (RR 0.27; 95% CI 0.12 to 0.63).
- Pregnant Women: No major side effects were reported for casirivimab/imdevimab in pregnant women, though the limited availability of standardized clinical trials in this population underscores the need for further research.
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 |