Regeneron Stock – REGEN-COV (casirivimab and imdevimab) FDA Approval Status
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 for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
- 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 12, 2021||Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19|
|Apr 12, 2021||Phase 3 Prevention Trial Showed 81% Reduced Risk of Symptomatic SARS-CoV-2 Infections with Subcutaneous Administration of REGEN-COV™ (casirivimab with imdevimab)|
|Apr 9, 2021||NIH COVID-19 Treatment Guidelines Strongly Recommend Use of REGEN-COV™ (casirivimab with imdevimab) in Outpatients at High Risk of Clinical Progression|
|Mar 23, 2021||Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patient|
|Feb 25, 2021||Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV™ (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial|
|Jan 27, 2021||REGEN-COV™ Antibody Cocktail Is Active Against SARS-CoV-2 Variants First Identified in the UK and South Africa|
|Jan 26, 2021||Regeneron Reports Positive Interim Data with REGEN-COV Antibody Cocktail used as Passive Vaccine to Prevent COVID-19|
|Jan 12, 2021||Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses|
|Dec 17, 2020||New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19|
|Nov 21, 2020||Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization|
|Nov 5, 2020||RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients|
|Oct 30, 2020||REGN-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, 2020||Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention|
|Oct 2, 2020||Regeneron Confirms that REGN-COV2 Antibody Cocktail Provided to President Trump Under Compassionate Use Request|
|Sep 29, 2020||Regeneron’s REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients|
|Aug 18, 2020||Genentech and Regeneron Collaborate to Significantly Increase Global Supply of REGN-COV2 Investigational Antibody Combination for COVID-19|
|Jul 7, 2020||Regeneron Announces Manufacturing and Supply Agreement for (BA)RDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail|
|Jul 6, 2020||Regeneron Announces Start of REGN-COV2 Phase 3 COVID-19 Prevention Trial in Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)|
|Jun 11, 2020||Regeneron Begins First Clinical Trials of Anti-Viral Antibody Cocktail REGN-COV2 for the Treatment and Prevention of COVID-19|
|Mar 17, 2020||Regeneron Announces Important Advances in Novel COVID-19 Antibody Program|
|Feb 4, 2020||Regeneron Announces Expanded Collaboration with HHS to Develop Antibody Treatments for New Coronavirus|
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