Bamlanivimab and Etesevimab COVID-19 Monoclonal Antibody Treatment 2022
Eli Lilly's Bamlanivimab (LY-CoV555) neutralizing IgG1 monoclonal antibody (mAb) is directed against the spike protein of the SARS-CoV-2 coronavirus. Bamlanivimab was designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19 patients. Bamlanivimab emerged from the collaboration between Lilly and AbCellera.
Lilly scientists developed the mAb in less than three months and tested them at the NIAID Vaccine Research Center. Bamlanivimab and etesevimab do not have any COVID-19 virus in them. Etesevimab (LY-CoV016, JS016) is a recombinant fully human monoclonal neutralizing antibody. Eli Lilly licensed etesevimab from Junshi Biosciences after jointly developed by Junshi and the Institute of Microbiology, Chinese Academy of Science.
On February 9, 2021, the U.S. FDA authorized bamlanivimab and etesevimab administered together to treat mild-to-moderate COVID-19 in adults and certain pediatric patients. On December 3, 2021, the FDA issued a revised EUA for bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. In addition, this revision also authorizes bamlanivimab and etesevimab to be administered together for post-exposure prophylaxis to prevent COVID-19 in all pediatric patients, including newborns, at high risk of progression severe COVID-19, including hospitalization or death.
As of January 24, 2022, the FDA revised the authorization for bamlanivimab and etesevimab administered together to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Therefore, these treatments are 'Paused' for use in any U.S. states, territories, and jurisdictions at this time.
AbCellera is a Canadian technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. For more information, visit www.abcellera.com.
Based in Indianapolis, Indiana, Eli Lilly (LLY) is a global healthcare leader who unites caring with discovery to create medicines that make life better for people worldwide. To learn more about Lilly, please visit www.lilly.com. For more information about Lilly's COVID-19 therapies authorized for emergency use, contact the Lilly COVID Hotline at 1-855-LillyC19 (1-855-545-5921).
Etesevimab Monoclonal Neutralizing Antibody
Etesevimab binds explicitly to the SARS-CoV-2 surface spike protein receptor-binding domain high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. In addition, point mutations were introduced into the native human IgG1 antibody to mitigate effector function. As a result, the U.S. FDA published a revised Fact Sheet on March 20, 2021. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and globally as initiated Phase 1b/2 trials in COVID-19 patients. Junshi Biosciences (HKEX: 1877; SSE: 688180) leads development in Greater China, while Lilly leads growth in the rest of the world. In addition, a Phase 2 study assessing the efficacy and safety of bamlanivimab alone and bamlanivimab with other neutralizing antibodies versus placebo to treat symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment.
Bamlanivimab and Etesevimab COVID-19 Antibody Effectiveness Against Omicron Variant
As of February 3, 2022, the U.S. NIH's OpenData Portal reported in vitro Therapeutic Activity against the Omicron variant. Anti-SARS-CoV-2 mAbs that target the spike protein have been shown to have a clinical benefit in treating SARS-CoV-2 infection. But, given the breaking nature of these releases, Omicron data should be interpreted with caution. On January 19, 2022, a U.S. NIH Panel stated the Omicron VOC has numerous mutations in the spike protein, is predicted to have markedly reduced susceptibility to Bamlanivimab and Etesevimab.
Bamlanivimab and Etesevimab COVID-19 Antibody Availability 2022
Since September 13, 2021, about 850,000 treatments were shipped in the U.S. On February 7, 2022, the U.S. HHS Assistant Secretary for Preparedness and Response confirmed (0) doses of Bamlanivimab and Etesevimab were recently distributed in the U.S. The FDA has 'Paused' its authorization for this mAbs. Please see The Panel's Updated Statement on the Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies.
Patients and physicians can visit the NICA Infusion Center Locator or the HHS Therapeutics Distribution locator to find a potential therapy location. In addition, a current list of countries with a purchase agreement and regulatory authorization is found on this Eli Lilly webpage.
Bamlanivimab and Etesevimab COVID-19 Antibody Treatment History
On November 9, 2020, the U.S. FDA issued a EUA for a single infusion of 700 mg bamlanivimab to treat mild-to-moderate COVID-19 in adult and certain pediatric patients. This EUA was revoked on March 2, 2021. On January 26, 2021, Lilly announced new data showing treatment with the neutralizing antibodies bamlanivimab and etesevimab reduces the risk of COVID-19 hospitalizations and death by 70%. On May 11, 2021, the US Centers for Medicare & Medicaid Service (CMS) confirmed the investigational monoclonal antibody therapies are available under FDA EUA.
Bamlanivimab and Etesevimab COVID-19 Antibody Treatment Indication for Children
Bamlanivimab and Etesevimab treatment is indicated to prevent or mitigate the progression of COVID-19 infection caused by the SARS-CoV-2 coronavirus. Bamlanivimab and etesevimab were authorized on December 3, 2021, as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under the age of 12; the EUA was extended for the pediatric and infant population.
Bamlanivimab and Etesevimab COVID-19 Antibody Dosage
The authorized dosage for adults and certain pediatric patients (weighing at least 40 kg) is 700 mg bamlanivimab and 1,400 mg of etesevimab administered together as a single intravenous infusion. Patients weighing less than 40 kg (88 pounds) received doses of bamlanivimab and etesevimab adjusted for their body weight to achieve comparable exposures to adults and adolescents receiving the authorized dose. Given the similar course of COVID-19 disease, the authorization of bamlanivimab and etesevimab in younger pediatric patients, including neonates, is supported by safety and efficacy data in adolescents and adults, together with additional pharmacokinetic and safety data from the clinical trial in pediatric patients. The youngest participant in the pediatric clinical trial was ten months of age and weighed 8.6 kg [see Clinical Trials and Supporting Data for EUA (18.1)]
Bamlanivimab and Etesevimab COVID-19 Treatment Side Effects and Safety
There are limited clinical data available for bamlanivimab and etesevimab. Serious and unexpected adverse events may occur that have not been previously reported using bamlanivimab and etesevimab together. Serious hypersensitivity reactions, including anaphylaxis, have been observed with the administration of bamlanivimab and etesevimab. Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Therefore, Bamlanivimab and etesevimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. And there are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
Anyone can submit a side effect report to VAERS, including parents and patients. And healthcare providers are required by law to report to VAERS.
Bamlanivimab and Etesevimab COVID-19 Antibody Treatment Guidelines 2022
The NIH updated the guidelines on January 19, 2022.
Bamlanivimab and COVID-19 Vaccination Benefits
A non-peer-reviewed study published on December 16, 2021, suggests a complementary role for COVID-19 mAbs with COVID-19 vaccines and that the benefit of receiving COVID-19 vaccination at the earliest opportunity outweighs the minimal effect on the endogenous immune response due to prior prophylactic COVID-19 mAb infusion. The impact of an anti-SARS-CoV-2 monoclonal antibody, bamlanivimab, on the endogenous immune response to COVID-19 vaccination study. All bamlanivimab and placebo study participants mounted a robust immune response following full COVID-19 vaccination, irrespective of age, risk category, and vaccine type, with any observed differences unlikely to be clinically meaningful.
Bamlanivimab and Etesevimab COVID-19 Antibody Financial News
February 3, 2022 - The Company reported the U.S. Government signed a purchase agreement for 614,000 additional doses of Lilly's bamlanivimab and etesevimab for the treatment or post-exposure prevention of COVID-19 for a total of $1.29 billion. There were approximately 435,000 doses delivered in the fourth quarter of 2021, with most of the remaining doses already shipped in January 2022. The company recognized U.S. revenue from COVID-19 antibodies of $1.029 billion in the fourth quarter of 2021 compared to $850.0 million in the fourth quarter of 2020.
November 2, 2021 - Eli Lilly and Company announced an additional purchase by the U.S. government for bamlanivimab with etesevimab for administration together. As part of the agreement, a minimum of 400,000 doses will be supplied no later than December 31, 2021. And Lilly will supply 614,000 doses of bamlanivimab with etesevimab no later than January 31, 2022, for a total of $1.29 billion.
September 15, 2021 - Eli Lilly and Company (NYSE: LLY) announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship Q3 2021 and the remaining to be shipped in Q4 2021.
Bamlanivimab and Etesevimab COVID-19 Antibody Treatment News
February 3, 2022 - Eli Lilly reported the FDA has updated the Fact Sheet for bamlanivimab and etesevimab to include a new Limitation for Authorized Use: due to the high frequency of the Omicron variant, these antibody therapies are not currently authorized in any U.S. region. Authorization status will change as needed, depending on the prevalence and trends of variants of concern.
January 24, 2022 - Patrizia Cavazzoni, M.D., Director - Center for Drug Evaluation and Research, issued a statement: The FDA revised the authorizations for bamlanivimab and etesevimab (administered together) to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Therefore, this mAbs treatment is not authorized for use in any U.S. states, territories, and jurisdictions at this time.
January 19, 2022 - The U.S. NIH published an update that stated: Prior to mid-December 2021, the anti-SARS-CoV-2 mAbs casirivimab plus imdevimab was recommended by the Panel for non-hospitalized patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease. However, the Omicron VOC, which has numerous mutations in the spike protein, is predicted to have markedly reduced susceptibility to Bamlanivimab and Etesevimab.
December 23, 2021 - The Annals of Internal Medicine published results from a phase 3 clinical study that concluded the 'efficacy and safety of bamlanivimab may differ depending on whether an endogenous nAb response has been mounted.
December 23, 2021 - The U.S. FDA issued a revised Provider Fact Sheet.
December 3, 2021 - The U.S. FDA announced an expanded EUA for Bamlanivimab and Etesevimab to include younger people (12-)and newborns weighing less than 88 lbs.
December 1, 2021 - Mexico's Cofepris confirmed it had granted the emergency use of bamlanivimab and etesevimab to treat mild to moderate COVID-19 in people above the age of 12 who weigh at least 40 kilograms.
November 3, 2021 - Oxford academic published a manuscript: Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process. Conclusions - This study's finding supports the effectiveness of bamlanivimab in reducing Covid-19 related hospitalizations in patients ≥ 65 or with BMI ≥ 35 and suggests a mortality benefit.
November 2, 2021 - The EMA ended the rolling review of bamlanivimab and etesevimab for the treatment of COVID-19 developed by Elli Lilly Netherlands B.V. after the company informed the Agency that it was withdrawing from the process.
October 29, 2021 - Eli Lilly Netherlands B.V. informed the EMA of the decision to no longer continue with the ongoing submissions and responses under rolling review for an eventual marketing authorization application for bamlanivimab and etesevimab for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.
October 8, 2021 - The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration issued a Monoclonal Antibody Therapeutic Update for bamlanivimab/etesevimab. Effective immediately, ASPR will pause distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with the existing supply of bamlanivimab at a facility for use under EUA 094) to Hawaii because the Centers for Disease Control and Prevention (CDC) has identified that the Delta plus variant (B.1.617.2 sublineage AY.1) (initially identified in India) is circulating with a frequency exceeding 5% in Hawaii (CDC COVID Data Tracker). Results from in vitro assays that are used to assess the susceptibility of viral variants of SARS-CoV-2 to a particular monoclonal antibody therapy suggest that bamlanivimab and etesevimab administered together are not active against this variant. These assays use "pseudo-virus particles" that help determine the likely susceptibility of the live virus. Hawaii is not among the states FDA has listed in which the use of bamlanivimab and etesevimab administered together is authorized.
September 19, 2021 - Junshi Biosciences (HKEX: 1877; SSE: 688180) announced the U.S. FDA had expanded the emergency use authorization for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 mg administered together to include post-exposure prophylaxis in specific individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in institutional settings, including nursing homes and prisons.
September 16, 2021 - Carl Hansen, Ph.D., CEO and President of AbCellera, confirmed in a press release, "More than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives. With this expanded authorization, these antibodies, which are effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus."
September 2, 2021 - The Assistant Secretary for Preparedness and Response and the Food and Drug Administration within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.
August 27, 2021 - The U.S. Department of Health and Human Services confirmed it was resuming Eli Lilly's COVID-19 antibody cocktail therapy supply to states with low levels of SARS-CoV-2 coronavirus variants. The Office of the Assistant Secretary for Preparedness and Response had paused the distribution of bamlanivimab and etesevimab together (EUA 094) and etesevimab alone to pair with existing bamlanivimab as of June 25, 2021. This decision is related to the prevalence of the P.1 (Brazil) variant and the B.1.351 (South Africa) variant now circulating in these states.
August 20, 2021 - The U.S. Assistant Secretary for Preparedness and Response and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is currently authorized for emergency use only when administered together with etesevimab.
August 3, 2021 - Eli Lilly and Company (NYSE: LLY) announced financial results for the second quarter of 2021.
July 15, 2021 - The NEJM published an Original Article: Monoclonal Antibodies
and Vaccine Boosts. In this audio interview conducted on July 13, 2021, the editors discuss new studies of combination monoclonal therapy against Covid-19 and new evidence on vaccine boosts. This editorial is related to the phase 3 study's results published on July 14th.
July 14, 2021 - A study published by the NEJM concluded, 'Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19–related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load.'
June 25, 2021 - The FDA immediately pauses all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with the existing supply of bamlanivimab at a facility for use under EUA 094) on a national basis until further notice.
June 3, 2021 - The JAMA published an Orginal Investigation which concluded, 'Among residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection.' This randomized phase 3 clinical trial included 966 participants and staff at U.S. skilled nursing. It assisted living facilities with at least one confirmed SARS-CoV-2 index case and negative at baseline for SARS-CoV-2 infection and serology enrolled from August to November 2020. The incidence of COVID-19 infection among those treated with bamlanivimab vs. placebo was 8.5% vs. 15.2%, respectively, a statistically significant difference.
May 26, 2021 - The U.S. HHS issued a Public Health Notice: Distribution of this product to Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon, and Washington has been paused. Please see the updates for additional information.
May 17, 2021 - The University of Pittsburgh School of Medicine and UPMC physician-scientists published a new study in Open Forum Infectious Diseases that found Bamlanivimab monoclonal antibody monotherapy was associated with reduced hospitalizations and mortality within 28 days among outpatients with mild-moderate COVID-19. After adjustment for propensity to receive treatment, bamlanivimab treatment was associated with a significantly reduced risk-adjusted odds of hospitalization or mortality within 28 days (OR 0.40, 95% confidence interval [95% CI] 0.24 to 0.69; p<.001). Bamlanivimab treatment was also associated with a significantly lower risk-adjusted odds of hospitalization or emergency department visit without hospitalization (OR 0.54, 95% CI 0.35 to 0.82; p=.004).
April 16, 2021 - Eli Lilly and Company requested the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bamlanivimab (LY-CoV555) 700 mg alone. Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request is not due to any new safety concerns.
April 12, 2021 - Eli Lilly and Company announced Lilly and the U.S. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on the supply of bamlanivimab and etesevimab together. Additionally, the bamlanivimab and etesevimab agreement has been changed to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased. This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses scheduled to be delivered to the U.S. government by the end of March 2021.
April 8, 2021 - The U.S. NIH announced data are emerging on the currently available anti-SARS-CoV-2 monoclonal antibodies, including preliminary data from a Phase 3 trial of casirivimab plus imdevimab in vitro susceptibility of SARS-CoV-2 variants to anti-SARS-CoV-2 monoclonal antibodies. After reviewing the available data, the COVID-19 Treatment Guidelines Panel (the Panel) has updated its recommendations on anti-SARS-CoV-2 monoclonal antibodies in outpatients with mild to moderate COVID-19 who are at high-risk disease progression. Also, the Panel notes that, because of an increasing number of reports of variants that are resistant to bamlanivimab alone, this product will no longer be distributed by the U.S. government.
March 29, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day seven compared to placebo, meeting the primary endpoint. Also, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in the SARS-CoV-2 virus viral load.
March 17, 2021 - Endpoint News reported the U.S. government is no longer distributing Eli Lilly's bamlanivimab into California, Arizona, and Nevada because of the prevalence of a viral variant that is not susceptible to the monoclonal antibody, FDA acting commissioner Janet Woodcock announced in a webinar with the AMA.
March 11, 2021 - The EMA's human medicines committee has started a 'rolling review' of data on the antibodies bamlanivimab and etesemivab, developed by Indiana-based Eli Lilly and Company, to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
March 10, 2021 - Eli Lilly announced new data from the BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.
March 5, 2021 - Eli Lilly and Company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises that bamlanivimab alone and bamlanivimab administered together with etesevimab can be used to treat confirmed COVID-19 in patients aged rs and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
February 26, 2021 - Eli Lilly and Company announced the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together; Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
February 23, 2021 - The COVID-19 Treatment Guidelines Panel's Statement on the Emergency Use Authorization of the Bamlanivimab Plus Etesevimab Combination for the Treatment of COVID-19: Bamlanivimab and etesevimab are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the receptor-binding domain of the spike protein of the SARS-CoV-2 coronavirus.
February 17, 2021 - LETTER TO THE EDITOR published by Wiley: Bamlanivimab to treat COVID‐19 in solid organ transplant recipients: An early single‐center experience. In this study, following the administration of Bamlanivimab to solid organ transplant patients diagnosed with mild‐moderate COVID‐19 in a non-hospitalized setting, no patient experienced symptom worsening or required hospitalization.
February 9, 2021 - The U.S. FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The EUA use includes treatment for 65 years of age or older or certain chronic medical conditions.
February 4, 2021 - The European Medicine Agency announced the human medicines committee is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab, and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews: the casirivimab/imdevimab combination and another for bamlanivimab/etesevimab.
January 27, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.
January 26, 2021 - Eli Lilly announced Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004).
January 21, 2021 - Eli Lilly and Company's Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, according to the Phase 3 BLAZE-2 COVID-19 prevention trial. After all of the study participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021).
January 21, 2021 - JAMA Network Original Investigation - Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19. A Randomized Clinical Trial Conclusions and Relevance: 'Among non-hospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11. No significant difference in viral load reduction was observed for bamlanivimab monotherapy.
December 28, 2020 - Governor Greg Abbott and the Texas Department of State Health Services are alerting nursing facilities to the availability of monoclonal antibody therapies that can be used to treat residents who have been diagnosed with COVID-19. Commissioner John Hellerstedt, MD, urges facility administrators to work with their medical directors and treating physicians to consider the use of monoclonal antibodies whenever appropriate.
December 18, 2020 - Eli Lilly and Company announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, collaborating with major local institutions in the state of New Mexico. Conducting the study in New Mexico will allow collecting data on the effectiveness and safety of bamlanivimab in a real-world setting that includes a diverse population and spans both rural and urban environments.
December 11, 2020 - JAMA article: he investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization.
December 2, 2020 - The U.S. government has purchased 650,000 additional doses of the neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The doses will be delivered through January 31, 2021, with at least 350,000 extra doses delivered in December 2020. Bamlanivimab recently received emergency use authorization to treat mild to moderate COVID-19 patients at high risk for progressing to severe COVID-19 and/or hospitalization. This purchase brings the total doses purchased by the U.S. government to 950,000.
November 24, 2020 - 1st patient receiving Covid-19 antibody infusion at El Paso Convention Center hospital announced. The alternate care site was provided with 1,000 doses of bamlanivimab, a monoclonal antibody therapy created by Eli Lilly & Company recently approved for emergency use by the FDA.
November 20, 2020 - Health Canada granted authorization under the Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
November 19, 2020 - Texas Governor Greg Abbott updated the distribution of bamlanivimab, the Eli Lilly & Company monoclonal antibody therapy for COVID-19. The Texas Department of State Health Services has allocated this initial shipment of bamlanivimab to acute care hospitals across Texas.
November 13, 2020 - A new study in Italy found Baricitinib as possessing anti-viral and anti-cytokine efficacy. This limited study showed a 71% (95% CI 0.15-0.58) mortality benefit in 83 patients with moderate-severe SARS-CoV-2 pneumonia, with few drug-induced adverse events, including a large elderly cohort (median age 81 years).
November 9, 2020 - Eli Lilly announced the U.S. FDA granted Emergency Use Authorization for the investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The authorization allows for the distribution and emergency use of bamlanivimab administered via a single intravenous infusion.
October 28, 2020 - Eli Lilly and Company announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The initial agreement is for delivery over the two months following authorization and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021.
October 26, 2020 - The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). It is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab.
October 14, 2020 - Lilly announced it continues to communicate with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause the study's enrollment. ACTIV-3 evaluates Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients.
October 8, 2020 - Junshi Biosciences announced that its global partner Eli Lilly and Company announced positive interim data on combination therapy with neutralizing antibodies JS016 (LY-CoV016) LY-CoV555 in recently diagnosed patients with mild-to-moderate COVID-19 illness.
October 7, 2020 - Lilly provides a comprehensive update on the progress of SARS-CoV-2 neutralizing antibody programs.
October 1, 2020 - Non-peer-reviewed study: LY-CoV555, a rapidly isolated potent neutralizing antibody, protects in a non-human primate model of SARS-CoV-2 infection.
September 16, 2020 - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced hospitalization rate for patients treated with LY-CoV555.
August 3, 2020 - Lilly Initiates Phase 3 Trial of LY-CoV555 to prevent COVID-19 at Long-Term Care Facilities in Partnership with the National Institute of Allergy and Infectious Diseases (NIAID).
June 1, 2020 - Eli Lilly and Company announced patients had been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19.
Bamlanivimab COVID-19 Antibody Treatment Clinical Trials
Eli Lilly continues to test Bamlanivimab in clinical trials.