Drugs / Etesevimab
Etesevimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Bamlanivimab and etesevimab for COVID-19 | — | 2021-10-29 | europa.eu ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04611789 | Nov 2020 → Feb 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04441931 | Jun → Oct 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04441918 | Jun → Dec 2020 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Unknown | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT04931238 | Jan → Dec 2021 | COVID-19 | Peking Union Medical College Hospital | Unknown | Missed primary |
| Phase 2 | NCT04634409 | Oct 2020 → Jul 2021 | COVID-19 | Eli Lilly and Company | Completed | Mixed |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04427501 | Jun 2020 → Feb 2023 | COVID-19 | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05205759 | Dec 2021 → Feb 2022 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Terminated | No outcome recorded |
| Phase 3 | NCT04497987 | Aug 2020 → Jan 2021 | COVID-19 | Eli Lilly and Company | Completed | Met primary |
| Phase 41 trial · 1 missed | ||||||
| Phase 4 | NCT04790786 | Mar 2021 → Jun 2022 | COVID-19 | Erin McCreary | Terminated | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05167279 Comparator | Dec 2021 → Dec 2022 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT04780321 Comparator | Oct 2020 → Aug 2021 | COVID-19 | Shanghai Junshi Bioscience Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2021-12-03 | AbCellera Biologics Inc. | Regulatory AbCellera-Discovered Bamlanivimab Together with Etesevimab Authorized as the First and Only Antibody Therapy for Emergency Use in COVID-19 Patients Under the Age of 12 abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include pediatric patients under the age of 12, including neonates (infants <1 year old). |
| 2021-12-03 | Eli Lilly and Company | Regulatory Lilly's bamlanivimab with etesevimab authorized as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under the age of 12 lilly.com ↗
The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab administered together to include certain high-risk pediatric patients from birth to <12 years old, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-09-16 | AbCellera Biologics Inc. | Regulatory Emergency Use Authorization of AbCellera-Discovered Bamlanivimab Administered with Etesevimab Expanded by the FDA to Include Post-Exposure Prophylaxis for the Prevention of COVID-19 abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg administered with etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis (PEP) to prevent SARS-CoV-2 infection or symptomatic COVID-19. |
| 2021-09-16 | Eli Lilly and Company | Regulatory Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19 lilly.com ↗
This authorization follows the national reopening of distribution earlier this month. |
| 2021-03-10 | AbCellera Biologics Inc. | Results AbCellera-Discovered Bamlanivimab Together with Etesevimab Reduced Hospitalizations and Prevented Death in Phase 3 Trial for Early COVID-19 abcellera.com ↗
Patients who received bamlanivimab and etesevimab together had an 87% reduction in hospitalizations and death; no patients died who received the therapy |
| 2021-03-10 | Eli Lilly and Company | Results Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19 lilly.com ↗
There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 percent risk reduction (p<0.0001). |
| 2021-03-05 | AbCellera Biologics Inc. | Regulatory EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients abcellera.com ↗
AbCellera (Nasdaq: ABCL) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. |
| 2021-03-05 | Eli Lilly and Company | Regulatory EMA issues advice on Lilly's bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union lilly.com ↗
Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. |
| 2021-02-09 | AbCellera Biologics Inc. | Regulatory AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Receives FDA Emergency Use Authorization for COVID-19 abcellera.com ↗ |
| 2021-02-09 | Eli Lilly and Company | Regulatory Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19 lilly.com ↗
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2021-01-26 | AbCellera Biologics Inc. | Results AbCellera-Discovered Antibody, Bamlanivimab, Administered with Etesevimab Reduced Risk of COVID-19 Hospitalizations and Death by 70% abcellera.com ↗
Bamlanivimab and etesevimab together reduced COVID-19 events by 70% versus placebo (p=0.0004); |
| 2021-01-26 | Eli Lilly and Company | Results New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 percent lilly.com ↗
Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. |
| 2020-10-07 | Eli Lilly and Company | Results Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs lilly.com ↗
Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly's SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits. |
All press releases naming this drug 19 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etesevimab | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | Anti-sars-cov-2 antibody js016 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650488 ↗ |
| Known as | CB6 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | JS016 | “intravenous Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody (JS016)” NCT04780321 ↗ |
| Known as | LY-CoV016 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | LY3832479 | “This study is the first to report the tolerability, safety, pharmacokinetics (PK), and immunogenicity of a recombinant human anti-SARS-CoV-2 monoclonal antibody, etesevimab...” PMID 33972256 ↗ Jul 2021 |
| Known as | NP-005 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650488 ↗ |
| Action | Inhibit | “JS016 showed neutralizing and therapeutic effects” PMID 35191746 ↗ Mar 2022 |
| Modality | Monoclonal antibody | “a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together)” PMID 34260849 ↗ Jul 2021 |
| Route | Intravenous | “Administered IV” NCT04427501 ↗ |