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REGEN-COV FDA Approval Status

Last updated by Judith Stewart, BPharm on Aug 6, 2021.

FDA Approved: No (Emergency Use Authorization)
Brand name: REGEN-COV
Generic name: casirivimab and imdevimab
Previous name: Regeneron antibody cocktail
Dosage form: Infusion
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: COVID-19

REGEN-COV is a combination of two monoclonal antibodies (casirivimab and imdevimab) designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.

  • The casirivimab and imdevimab antibody cocktail (REGEN-COV) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on November 21, 2020. Casirivimab and imdevimab injection is not FDA approved for any use.
  • Casirivimab and imdevimab administered together are authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing ≥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.
  • On July 30, 2021, the FDA updated the EUA for REGEN-COV to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).
  • Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19.
  • The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

Development timeline for REGEN-COV

Apr 14, 2022U.S. FDA Extends Review of Biologics License Application for REGEN-COV® (casirivimab and imdevimab) for Treatment and Prophylaxis of COVID-19
Jan 24, 2022Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
Nov  8, 2021New Phase 3 Analyses Show That a Single Dose of REGEN-COV® (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19
Oct 14, 2021FDA Accepts REGEN-COV (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19
Sep 30, 2021New REGEN-COV (casirivimab and imdevimab) Data Show Supportive Results in Patients Hospitalized with COVID-19
Sep 14, 2021Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail
Aug  4, 2021New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection
Jul 30, 2021FDA Expands Authorized Use of REGEN-COV (casirivimab and imdevimab)
Jun 16, 2021REGEN-COV™ (casirivimab and imdevimab) Phase 3 RECOVERY Trial Meets Primary Outcome, Improving Survival in Hospitalized COVID-19 Patients Lacking an Immune Response to SARS-CoV-2
Jun  4, 2021FDA Authorizes Lower 1,200 mg Intravenous and Subcutaneous Dose of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail to Treat Patients with COVID-19
May 17, 2021Phase 3 Data Presented at ATS 2021 Show REGEN-COV™ (casirivimab with imdevimab) Reduced Risk of Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients
Apr 12, 2021Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19
Apr 12, 2021Phase 3 Prevention Trial Showed 81% Reduced Risk of Symptomatic SARS-CoV-2 Infections with Subcutaneous Administration of REGEN-COV (casirivimab with imdevimab)
Apr  9, 2021NIH COVID-19 Treatment Guidelines Strongly Recommend Use of REGEN-COV™ (casirivimab with imdevimab) in Outpatients at High Risk of Clinical Progression
Mar 23, 2021Phase 3 Trial Shows REGEN-COV (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patient
Feb 25, 2021Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial
Jan 27, 2021REGEN-COV Antibody Cocktail Is Active Against SARS-CoV-2 Variants First Identified in the UK and South Africa
Jan 26, 2021Regeneron Reports Positive Interim Data with REGEN-COV Antibody Cocktail used as Passive Vaccine to Prevent COVID-19
Jan 12, 2021Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses
Dec 17, 2020New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19
Nov 21, 2020Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization
Nov  5, 2020RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients
Oct 30, 2020REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements
Oct 28, 2020Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention
Oct  2, 2020Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request
Sep 29, 2020Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients
Aug 18, 2020Genentech and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19
Jul  7, 2020Regeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail
Jul  6, 2020Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)
Jun 11, 2020Regeneron Begins First Clinical Trials of Anti-Viral Antibody Cocktail REGN-COV2 for the Treatment and Prevention of COVID-19
Mar 17, 2020Regeneron Announces Important Advances in Novel COVID-19 Antibody Program
Feb  4, 2020Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus

Further information

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