Drug updated on 5/17/2024
| 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.
Latest News
Summary
- Casirivimab and imdevimab (REGEN-COV) are used for the treatment of mild to moderate COVID-19 in adult and pediatric patients who have tested positive for SARS-CoV-2, particularly those at high risk for severe disease progression.
- Fourteen systematic reviews/meta-analyses provided information on the safety, effectiveness, comparisons with other treatments, and subgroup considerations related to casirivimab and imdevimab.
- The drug combination significantly reduces mortality rates and clinical symptom progression in COVID-19 patients while also facilitating viral load clearance.
- For pregnant women specifically, treatment with casirivimab/imdevimab has been shown to decrease the need for cesarean sections without significant impact on other pregnancy-related outcomes or disease progression.
- Compared to anti-SARS-CoV antibody regimens such as bamlanivimab alone or combined with etesevimab, casirivimab/imdevimab was ranked among treatments that notably reduced mortality, especially in baseline seronegative patients.
- Studies indicate that tocilizumab shows statistically favorable outcomes compared to standard care when treating severe cases of COVID-19. This highlights the need for careful consideration of patient risk factors before administering monoclonal antibodies like REGEN-COV.
- The use of this medication is associated with a reduction in hospitalization risks among high-risk infected individuals, potentially reducing ICU admission rates and invasive ventilation rates, albeit uncertainties exist around these findings.
- In terms of subgroup considerations, it's important to note that more focused research is needed within specific subgroups such as pregnant women, where no significant effect was observed regarding disease progression despite noted prevention against cesarean sections by CAS/IMD. Also, considering patients’ serostatus prior to administering monoclonal antibodies for COVID-19 is crucial.
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 Ă„rzteblatt International |