On January 24, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment. With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions, since Omicron is currently the dominant variant across the United States. REGEN-COV remains an investigational drug and is not approved for any indication. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas. Healthcare providers should refer to the REGEN-COV authorized fact sheet for healthcare providers for additional information.
Per the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR), product return is not recommended. If product must be returned, healthcare providers may call 1-844-734-6643.
Healthcare providers and patients may view the January 24th FDA statement and FDA fact sheets below. You may also contact Regeneron Medical Information at 1-844-734-6643, or at [email protected]
REGEN-COV (casirivimab and 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
Treatment:
REGEN-COV 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 progression to severe COVID-19, including hospitalization or death.
Limitations of Authorized Use (Treatment)
Post-Exposure Prophylaxis:
REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
Limitations of Authorized Use (Post-Exposure Prophylaxis)
REGEN-COV has not been approved, but has been authorized for emergency use by FDA
These uses are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized uses of REGEN-COV and mandatory requirements of the EUA and must comply with the requirements of the EUA. The FDA Letter of Authorization is available for reference, as well as the Dear Healthcare Provider Letter and Patient Fact Sheet
Criteria for Identifying High Risk Individuals
Please refer to the Fact Sheet for Healthcare Providers for criteria for identifying high risk individuals.
Reporting Adverse Events
*Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series (such as the Pfizer or Moderna vaccines), or 2 weeks after a single-dose vaccine (such as Johnson & Johnson’s Janssen vaccine). See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated
†See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html
‡Close contact with an infected individual is defined as: being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example). See this website for additional details: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html
1. Centers for Medicare & Medicaid Services. Monoclonal Antibody COVID-19 Infusion. https://www.cms.gov/medicare/covid-19/monoclonal-antibody-covid-19-infusion. Accessed August 25, 2021.
2. Medicaid. Coronavirus Disease 2019 (COVID-19). https://www.medicaid.gov/resources-for-states/disaster-response-toolkit/coronavirus-disease-2019-covid-19/index.html. Accessed August 25, 2021.
3. Health Resources & Services Administration. FAQs for COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment and Vaccine Administration. https://www.hrsa.gov/coviduninsuredclaim/frequently-asked-questions. Accessed August 25, 2021.
4. Update: Change in the Distribution Process of COVID-19 mAbs. Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services. ASPR Slide Deck. Accessed September 13, 2021.
1. O’Brien MP, Forleo Neto E, Musser BJ. Subcutaneous REGEN-COV antibody combination to prevent COVID-19. N Engl J Med. Published online August 4, 2021. doi: 10.1056/NEJMoa2109682.
1. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. National Institutes of Health.
https://www.covid19treatmentguidelines.nih.gov/. Accessed August 17th, 2021.
1. Weinreich DM, et al. N Engl J Med. 2021. doi:10.1056/NEJMoa2108163.
REGEN-COV (casirivimab and 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
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.