Drug updated on 4/17/2024
| 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.
Summary
- Casirivimab and imdevimab (REGEN-COV) is recommended for the management of mild to moderate COVID-19 in adult and pediatric patients at high risk of progressing to severe disease, including the risk of hospitalization or death. This monoclonal antibody therapy has proven effective in decreasing hospitalizations and death rates.
- Fourteen studies were analyzed, focusing on various strategies for COVID-19 management, with a particular emphasis on the safety and effectiveness of casirivimab and imdevimab (REGEN-COV).
- REGEN-COV was found to have a slight decrease in adverse events compared to other treatment options, indicating a favorable safety profile. It has a lower risk of causing or worsening adverse events, making it suitable for early intervention.
- REGEN-COV significantly lowered the risk of hospitalization and the progression of clinical symptoms in non-hospitalized patients compared to placebo or standard care.
- For pregnant women, the use of REGEN-COV, along with other therapies like remdesivir, reduced the necessity for cesarean sections without impacting the risks of preterm delivery or maternal death rates, suggesting potential advantages for this specific group.
- Comparisons of different monoclonal antibodies against COVID-19 revealed that bamlanivimab plus etesevimab significantly reduced mortality, whereas REGEN-COV was effective only among seronegative patients, underscoring the importance of considering a patient's serostatus before treatment.
- Strategies such as convalescent plasma did not show similar levels of efficacy and could increase the odds of adverse events, contrasting with the favorable safety profile offered by REGEN-COV.
- The efficacy of monoclonal antibody treatment, including REGEN-COV, was more pronounced among seronegative individuals, suggesting that prior infection or vaccination status may influence treatment outcomes.
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 |