Author: [AUTHOR] Published on 9/10/2021 5:00:00 AM
FDA Authorizes REGEN-COV Monoclonal Antibody Therapy for Post-Exposure Prophylaxis (Prevention) for COVID-19
On July 30, 2021, the US Food and Drug Administration (FDA) revised the emergency use authorization (EUA) for REGEN-COV (casirivimab and imdevimab, administered together) to authorize REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent COVID-19 before being exposed to the SARS-CoV-2 virus – only after exposure to the virus.
REGEN-COV should only be used as post-exposure prophylaxis for individuals who are not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and:
- have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
- who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)
The authorized dosage of REGEN-COV for post-exposure prophylaxis is 600 mg of casirivimab and 600 mg of imdevimab administered by subcutaneous (SC) injection or together as a single intravenous (IV) infusion as soon as possible following exposure to SARS-CoV-2. For individuals in whom repeat dosing is determined to be appropriate for ongoing exposure to SARS-CoV-2 for longer than 4 weeks and who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination, the initial dose is 600 mg of casirivimab and 600 mg of imdevimab by SC injection or IV infusion followed by subsequent repeat dosing of 300 mg of casirivimab and 300 mg of imdevimab by SC injection or IV infusion once every 4 weeks for the duration of ongoing exposure. The authorized dosage for repeat dosing is based on the totality of the scientific evidence including clinical pharmacology data and clinical trial data.
Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death. FDA urges you to get vaccinated, if you are eligible. Learn more about FDA-authorized COVID-19 vaccines at https://go.usa.gov/xFRBT.
REGEN-COV remains authorized for the treatment of mild-to-moderate 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. The updated Fact Sheet for Health Care Providers provides essential information about using REGEN-COV administered together for treatment and prevention of COVID-19 as authorized and is available at https://go.usa.gov/xFRBc
. An updated fact sheet for patients, parents, and caregivers is available at https://go.usa.gov/xFRBg
and contains information for understanding the potential risks and potential benefits of taking REGEN-COV, including side effects.
The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. For additional information on the EUA authority and EUAs for COVID-19, please visit https://go.usa.gov/xs8x4
To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, FDA’s Center for Drug Evaluation and Research (CDER) recently launched a new webpage to facilitate access to information from CDER’s scientific review documents supporting EUAs for drug and biological therapeutic products that the Agency has disclosed. This webpage compiles the scientific review documents supporting EUAs for COVID-19 drug and biological therapeutic products that the Agency has disclosed into one location to make documents easier to find and can be accessed at https://go.usa.gov/xsHzW
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.