Updates for REGEN-COV Emergency Use Authorization (EUA) - Drug Information Update

U.S. Food and Drug Administration sent this bulletin at 06/08/2021 04:46 PM EDT

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FDA Center for Drug Evaluation and Research Division of Drug Information

Updates for REGEN-COV Emergency Use Authorization (EUA)

On June 3, 2021, FDA issued significant updates to the Emergency Use Authorization (EUA) for REGEN-COV (casirivimab and imdevimab), which is authorized for the treatment of mild to moderate COVID-19 in certain adults and pediatric patients.  

These recent updates include the following modifications: 

  • A change in the authorized dosage (from 1200mg of casirivimab and 1200mg of imdevimab to 600mg of casirivimab and 600mg of imdevimab)  

We note that the previous dosing of 1200mg of casirivimab and 1200mg of imdevimab is no longer authorized.   

  • The addition of subcutaneous route of administration as an alternative route when intravenous infusion is not feasible and would lead to delay in treatment 
  • The addition of a new REGEN-COV co-formulated product in a single vial.  

The updated Fact Sheet for Health Care Providers, Regeneron’s Important Prescribing Information and Frequently Asked Questions are available on FDA’s website.  

We encourage you to please share this updated information widely among your stakeholders and members. If you have questions regarding these updates, you may reach us at COVID19Therapeutics@HHS.gov. We appreciate your continued partnership in fighting the COVID-19 pandemic.