REGEN-COV is an investigational therapy and has been authorized by FDA for the emergency use described below. It is not FDA approved for any use, and its safety and effectiveness have not been fully established.
This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
START TREATMENTSee below for information regarding REGEN-COV and SARS-CoV-2 variants.
AUTHORIZED USE
REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults 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 progressing to severe COVID-19 and/or hospitalization.
Limitations of Authorized Use:
REGEN-COV is an investigational combination antibody treatment for COVID-19. The prepared treatment of REGEN-COV contains two different monoclonal antibodies, casirivimab and imdevimab, that bind to separate sites of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein receptor. Casirivimab and imdevimab must be administered together after dilution by intravenous (IV) infusion only.
Find information on how REGEN-COV is being distributed across the country and how to locate infusion sites near you.
If your patient (12 years of age or older and weighing at least 40 kg) with mild to moderate COVID-19 that has tested positive with direct viral testing, is within 10 days of symptom onset, and is at high risk for progressing to severe COVID-19 and/or hospitalization, they may be eligible to receive REGEN-COV.
REGEN-COV has been tested against, and was found to retain neutralization activity against, pseudoviruses expressing the spike protein substitution(s) identified in the below COVID-19 variants. It is not known how pseudovirus data correlate with clinical outcomes.
There is a potential risk of treatment failure due to the development of viral variants that are resistant to casirivimab and imdevimab administered together. Prescribing healthcare providers should consider the prevalence of SARS-CoV-2 variants in their area, where data are available, when considering treatment options.
It is not known how pseudovirus data correlate with clinical outcomes.
Location of Origin |
CDC Classification1 Data as of March 29, 2021. For the most up to date information, refer to the CDC. |
Spike Protein Substitutions Tested |
REGEN-COV Retained Neutralization Activity (Y/N)b |
---|---|---|---|
United Kingdom (B.1.1.7) |
Concern | Allc | Yes |
South Africa (B.1.351) |
Concern | Alld,e | Yes |
California (B.1.427/B.1.429) |
Concern | L452R | Yes |
Brazil (P.1) |
Concern | K417T + E484Kf | Yes |
New York (B.1.526) |
Interest | E484Kg,h | Yes |
Location of Origin: United Kingdom (B.1.1.7) |
---|
CDC Classification1 Concern Spike Protein Substitutions Tested Allc REGEN-COV Retained Neutralization Activity (Y/N)b Yes |
Location of Origin: South Africa (B.1.351) |
CDC Classification1 Concern Spike Protein Substitutions Tested Alld,e REGEN-COV Retained Neutralization Activity (Y/N)b Yes |
Location of Origin: California (B.1.427/B.1.429) |
CDC Classification1 Concern Spike Protein Substitutions Tested L452R REGEN-COV Retained Neutralization Activity (Y/N)b Yes |
Location of Origin: Brazil (P.1) |
CDC Classification1 Concern Spike Protein Substitutions Tested K417T + E484Kf REGEN-COV Retained Neutralization Activity (Y/N)b Yes |
Location of Origin: New York (B.1.) |
CDC Classification1 Interest Spike Protein Substitutions Tested E484Kg,h REGEN-COV Retained Neutralization Activity (Y/N)b Yes |
a As of March 18, 2021
b Defined as <2-fold reduction in susceptibility
c Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type spike protein are found in the variant: del69-70, del145, N501Y, A570D, D614G, P681H, T716I, S982A, D1118H.
d Pseudovirus expressing the entire variant spike protein was tested. The following changes from wild-type spike protein are found in the variant: D80Y, D215Y, del241-243, K417N, E484K, N501Y, D614G, A701V.
e Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K (which are found in this variant).
f Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing K417N or E484K.
g Casirivimab alone, but not imdevimab, had reduced activity against pseudovirus expressing E484K.
h Not all isolates of the New York lineage harbor E484K substitution (as of February 2021).
Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
Find out what comes next if you have a patient with COVID-19
Confirm the mild to moderate COVID-19 diagnosis and your patient’s eligibility (see below for full authorized use).
Confirm that the patient is at high risk, defined as a patient who meets at least one of the criteria.
Find an infusion center near your patient.
Write the order for REGEN-COV.
Share educational resources with your patient so they know what to expect.
Casirivimab and imdevimab must be administered together after dilution by IV infusion only.
The recommended dose of REGEN-COV under the EUA is 1,200 mg of casirivimab and 1,200 mg of imdevimab administered as a single IV infusion over at least 60 minutes.
The optimal dosing regimen for treatment for COVID-19 has not yet been established. The recommended dosing regimen may be updated as data from clinical trials become available.
ADDITIONAL GUIDANCEThe data supporting this EUA are based on the analysis of Phase 1/2 data from trial R10933-10987-COV-2067 that occurred after 799 enrolled subjects had completed at least 28 days of study duration.
REGEN-COV is also being studied in additional patient populations.
SEE CLINICAL TRIALS AND DATAREGEN-COV has not been approved, but has been authorized for emergency use by the FDA. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Food Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Educational videos, downloadable information for patients and healthcare providers, and external resources.
Have questions about REGEN-COV?
The development and manufacturing of casirivimab and imdevimab has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under OT number: HHSO100201700020C.
REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.
REGEN-COV (casirivimab with imdevimab to be administered together) is authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults 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 progressing to severe COVID-19 and/or hospitalization. [see Limitations of Authorized Use]
Limitations of Authorized Use:
Definition of High Risk Patients
High risk is defined as patients who meet at least one of the following criteria:
Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance, and refer to the CDC website as well as information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
1. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html
REGEN-COV (casirivimab with imdevimab) is an unapproved investigational therapy, and there are limited clinical data available. Serious and unexpected adverse events may occur that have not been previously reported with REGEN-COV use.
READ MORE
You are now leaving REGENCOV.com
Please note: By clicking on this link, you will be leaving this Regeneron-hosted US website and going to another independent website. Regeneron provides these links as a service to its website visitors and users; however, it takes no responsibility for the information on any website but its own.
This website www.regencov.com (the "site") uses "cookies". Cookies are small text files which are automatically placed on your computer by the internet browser when you visit the Site. A cookie can, amongst other things, track the web pages you visit and the options you use. Regeneron Pharmaceuticals, Inc. and its affiliates use this data to make the Site more user-friendly and efficient. We use Google Analytics cookie service to track and obtain reports on how visitors are using the Site. The information obtained with this cookie, which includes the IP address of your computer, will be transmitted to and stored by Google on servers in the United States. Google may share that information with third parties if Google is obliged to do so by law or to the extent such third parties are processing this information on behalf of Google. Regeneron has no influence on such use.