Drugs / imdevimab
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | US (FDA) | REGEN-COV | COVID-19 | — | “REGEN-COV, including based on the Biologics License Application filed with the U.S. Food and Drug Administration” regeneron.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Ronapreve | — | 2025-12-05 | europa.eu ↗ |
| Approved | EU (EMA) | Ronapreve | — | 2021-11-12 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05181683 | Jan → Jun 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05157997 | Jan 2022 → Jan 2024 | COVID-19 | Northwell Health | Withdrawn | No outcome recorded |
| Phase 1 | NCT05092581 | Dec 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT04519437 | Jul 2020 → Nov 2021 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05081388 | Nov 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04426695 | Jun 2020 → May 2021 | COVID-19 | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04992273 | Sep 2021 → Jun 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04852978 | Apr 2021 → Nov 2022 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT04666441 | Dec 2020 → Mar 2021 | COVID-19 | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT04840459 | Nov 2020 → Dec 2022 | COVID-19 | Sohail Rao | Unknown | No outcome recorded |
| Phase 33 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT05074433 | Oct 2021 → May 2022 | immunodeficiency disease | Regeneron Pharmaceuticals | Terminated | Missed primary |
| Phase 3 | NCT04452318 | Jul 2020 → Oct 2021 | — | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04425629 | Jun 2020 → Jan 2022 | COVID-19 | Regeneron Pharmaceuticals | Terminated | Met primary |
| Phase 42 trials · 1 missed | ||||||
| Phase 4 | NCT05502081 | Sep → Dec 2022 | COVID-19 | Mansoura University Hospital | Completed | Mixed |
| Phase 4 | NCT04790786 | Mar 2021 → Jun 2022 | COVID-19 | Erin McCreary | Terminated | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04617535 | — | COVID-19 | Regeneron Pharmaceuticals | No longer available | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1/2 | NCT04790240 Comparator | Jan 2025 → Dec 2026 expected | COVID-19 | All Natural Medicine Clinic, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT05041907 Comparator | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | Mixed |
| Phase 2/3 | NCT04518410 Comparator | Aug 2020 → Apr 2022 | COVID-19 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT05205759 Comparator | Dec 2021 → Feb 2022 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Terminated | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2022-04-14 | Regeneron Pharmaceuticals | Regulatory U.S. FDA Extends Review of Biologics License Application for REGEN-COV® (casirivimab and imdevimab) for Treatment and Prophylaxis of COVID-19 regeneron.com ↗
The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. |
| 2021-11-12 | Regeneron Pharmaceuticals | Regulatory Regeneron Antibody Cocktail Approved by European Commission to Treat and Prevent COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV® in the U.S. and Ronapreve™ in the European Union (EU) and other countries. |
| 2021-11-11 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends EU Approval of Regeneron Antibody Cocktail to Treat and Prevent COVID-19 regeneron.com ↗ |
| 2021-11-08 | Regeneron Pharmaceuticals | Results New Phase 3 Analyses Show That a Single Dose of REGEN-COV® (casirivimab and imdevimab) Provides Long-term Protection Against COVID-19 regeneron.com ↗
Single dose of REGEN-COV (1,200 mg subcutaneous) reduced the risk of COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction previously reported during month 1 |
| 2021-10-14 | Regeneron Pharmaceuticals | Regulatory FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19 regeneron.com ↗ |
| 2021-09-30 | Hoffmann-La Roche | Results Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19 roche.com ↗ |
| 2021-09-30 | Regeneron Pharmaceuticals | Results New REGEN-COV™ (casirivimab and imdevimab) Data Show Supportive Results in Patients Hospitalized with COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that a trial assessing investigational REGEN-COV™ (casirivimab and imdevimab) in patients hospitalized with COVID-19 met its primary endpoint. |
| 2021-09-29 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV™ (casirivimab and imdevimab) to Treat COVID-19 regeneron.com ↗
The trial met its primary and all secondary endpoints and showed treatment with REGEN-COV significantly reduced the risk of hospitalization or death, with a safety profile consistent with previously reported data. |
| 2021-08-20 | Regeneron Pharmaceuticals | Regulatory UK Authorizes Regeneron Antibody Cocktail to Prevent and Treat Acute COVID-19 Infection regeneron.com ↗
In addition to the CMA, which affects people in England, Scotland and Wales, the MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection for people in Northern Ireland. |
| 2021-08-04 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Phase 3 Trial Results for REGEN-COV™ (casirivimab and imdevimab) to Prevent SARS-CoV-2 Infection regeneron.com ↗
The trial met its primary endpoint, reducing the risk of symptomatic infections by 81% (p<0.001), with a 93% reduction of symptomatic infections after the first week, and no dose-limiting toxicities observed. |
| 2021-07-30 | Regeneron Pharmaceuticals | Regulatory FDA Expands Authorized Use of REGEN-COV™ (casirivimab and imdevimab) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for the investigational COVID-19 antibody cocktail REGEN-COV™ (casirivimab and imdevimab). |
| 2021-07-20 | Hoffmann-La Roche | Regulatory Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve™(casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. |
| 2021-07-20 | Regeneron Pharmaceuticals | Regulatory Japan Becomes First Country to Approve Regeneron Antibody Cocktail (casirivimab and imdevimab) for the Treatment of Mild to Moderate COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Regeneron's casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19. |
| 2021-06-16 | Regeneron Pharmaceuticals | Results REGEN-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 regeneron.com ↗ |
| 2021-06-04 | Regeneron Pharmaceuticals | Regulatory FDA Authorizes Lower 1,200 mg Intravenous and Subcutaneous Dose of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail to Treat Patients with COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. |
| 2021-05-17 | Regeneron Pharmaceuticals | Results Phase 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 regeneron.com ↗
The Phase 3 trial showed REGEN-COV helped patients avoid hospitalization or even death while speeding up recovery time. |
| 2021-05-03 | Regeneron Pharmaceuticals | Results ATS 2021 Breaking News Session to Feature Pivotal Data on REGEN-COV™ (casirivimab with imdevimab) and Dupixent® (dupilumab) regeneron.com ↗
Positive Phase 3 results from REGEN-COV trial in high-risk non-hospitalized patients with COVID-19 to be presented |
| 2021-04-12 | Hoffmann-La Roche | Results Phase III prevention trial showed subcutaneous administration of investigational antibody cocktail casirivimab and imdevimab reduced risk of symptomatic COVID-19 infections by 81% roche.com ↗
It showed that the subcutaneous administration of casirivimab and imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. |
| 2021-04-12 | Regeneron Pharmaceuticals | Results Phase 3 Treatment Trial in Recently Infected Asymptomatic Patients Showed REGEN-COV™ (casirivimab with imdevimab) Significantly Reduced Progression to Symptomatic COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous (SC) administration. |
| 2021-04-12 | Regeneron Pharmaceuticals | Results Phase 3 Prevention Trial Showed 81% Reduced Risk of Symptomatic SARS-CoV-2 Infections with Subcutaneous Administration of REGEN-COV™ (casirivimab with imdevimab) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from a Phase 3 trial (2069A) assessing the ability of REGEN-COV™ (casirivimab with imdevimab) to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. |
| 2021-03-23 | Hoffmann-La Roche | Results New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19 roche.com ↗
Casirivimab and imdevimab also met all key secondary endpoints in the phase III REGN-COV 2067 trial, including the ability to reduce symptom duration from 14 to 10 days (median numbers). |
| 2021-03-23 | Regeneron Pharmaceuticals | Results Phase 3 Trial Shows REGEN-COV™ (casirivimab with imdevimab) Antibody Cocktail Reduced Hospitalization or Death by 70% in Non-hospitalized COVID-19 Patients regeneron.com ↗ |
| 2021-02-26 | Hoffmann-La Roche | Regulatory EMA issues advice on casirivimab and imdevimab antibody cocktail for the treatment of mild-to-moderate COVID-19 roche.com ↗
CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency |
| 2021-02-26 | Regeneron Pharmaceuticals | Regulatory EMA Issues Advice on Regeneron's Antibody Cocktail (casirivimab with imdevimab) for Certain COVID-19 Patients regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's investigational COVID-19 antibody cocktail (casirivimab with imdevimab). |
| 2021-02-25 | Regeneron Pharmaceuticals | Results Independent Data Monitoring Committee Finds Clear Efficacy for REGEN-COV™ (casirivimab with imdevimab) in Phase 3 COVID-19 Outpatient Outcomes Trial regeneron.com ↗
The IDMC found clear clinical efficacy on reducing the rate of hospitalization and death with both the 1,200 mg and 2,400 mg doses of REGEN-COV compared to placebo, and recommended stopping enrollment into the placebo group. |
| 2021-02-01 | Vir Biotechnology, Inc. | Results Vir Biotechnology Announces New Data Highlighting the Importance of Targeting Conserved Regions of the SARS-CoV-2 Spike Protein in the Development of Therapeutics vir.bio ↗
When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant. |
| 2021-01-27 | Regeneron Pharmaceuticals | Results REGEN-COV™ Antibody Cocktail Is Active Against SARS-CoV-2 Variants First Identified in the UK and South Africa regeneron.com ↗
Although some antibody therapies were no longer effective against some of these variants, the REGEN-COV antibody cocktail continued to neutralize all variants tested. |
| 2021-01-26 | Regeneron Pharmaceuticals | Results Regeneron Reports Positive Interim Data with REGEN-COV™ Antibody Cocktail used as Passive Vaccine to Prevent COVID-19 regeneron.com ↗
Passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection (8/223 placebo vs. 0/186 REGEN-COV), and approximately 50% lower overall rates of infection (symptomatic and asymptomatic) (23/223 placebo vs. 10/186 REGEN-COV). |
| 2020-12-29 | Regeneron Pharmaceuticals | Results Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen regeneron.com ↗
The results passed the futility analysis (p<0.3 one-sided), as seronegative patients treated with the antibody cocktail had a lower risk of death or receiving mechanical ventilation (HR: 0.78; 80% CI: 0.51-1.2). |
| 2020-12-17 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. |
| 2020-11-21 | Regeneron Pharmaceuticals | Regulatory Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization regeneron.com ↗ |
| 2020-11-06 | Vir Biotechnology, Inc. | Results Vir Biotechnology Publishes New Research Characterizing Variation in the SARS-CoV-2 Spike Protein and Virulence of a Prevalent Immune Evasion Variant, N439K vir.bio ↗
When tested across four clinical-stage antibodies – S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 – S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant. |
| 2020-10-30 | Regeneron Pharmaceuticals | Results 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 regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. |
| 2020-10-28 | Regeneron Pharmaceuticals | Results Regeneron's COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention regeneron.com ↗
REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). |
| 2020-09-29 | Regeneron Pharmaceuticals | Results Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients regeneron.com ↗
REGN-COV2 also showed positive trends in reducing medical visits. |
All press releases naming this drug 38 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | imdevimab | “REGEN-COV (previously known as REGN-COV2), a combination of the monoclonal antibodies casirivimab and imdevimab, has been shown to markedly reduce the risk of hospitalization...” PMID 34347950 ↗ Aug 202119“Therefore, we performed a study to determine if the monoclonal antibody combination of casirivimab and imdevimab (CAS + IMD) can decrease the amount of virus in the nose of...” PMID 35895508 ↗ Dec 2022 “remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab \& Imdevimab.” NCT04790240 ↗ “All casirivimab and imdevimab treatments showed significant virologic reduction through day 7.” PMID 35969402 ↗ Aug 2022 “casirivimab 4 g and imdevimab 4 g administered together in a single intravenous infusion” PMID 35151397 ↗ Feb 2022 “Monoclonal antibodies: 600mg casirivimab/ 600mg imdevimab given once on D0” NCT05041907 ↗ “Imdevimab” NCT05271929 ↗ |
| Known as | REGN10987 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04519437 ↗ |
| Action | Inhibit | “blocking viral entry into host cells” PMID 35151397 ↗ Feb 2022 |
| Modality | Monoclonal antibody | “Casirivimab and imdevimab are non-competing monoclonal antibodies” PMID 35151397 ↗ Feb 2022 |
| Route | Intravenous | “administered together in a single intravenous infusion” PMID 35151397 ↗ Feb 2022 |