Lilly's bamlanivimab (LY-CoV555) administered with etesevimab (LY-CoV016) receives FDA emergency use authorization for COVID-19
INDIANAPOLIS, Feb. 9, 2021 /PRNewswire/ -- 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. This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system.
"Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit. Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world."
The EUA is based on Phase 3 data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate earlier results, published in The Journal of the American Medical Association, in a much larger group of patients. Additionally, the outcomes seen with bamlanivimab and etesevimab together are consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone. The most common adverse event more often reported for patients receiving bamlanivimab and etesevimab together versus placebo was nausea on the day of infusion.
While Phase 2 and Phase 3 trials evaluated a range of doses of bamlanivimab alone and bamlanivimab and etesevimab together, data demonstrated consistent and similar clinical effects among all doses studied. Additionally, initial results from an ongoing Phase 2 study provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated bamlanivimab 700 mg and etesevimab 1400 mg together produced similar effects to those observed in the Phase 3 trial with bamlanivimab 2800 mg and etesevimab 2800 mg together. Together, these data provide confidence in the authorized dose, which expands available supply to help more patients without sacrificing potential efficacy.
The FDA grants EUA to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This administration of bamlanivimab and etesevimab together is authorized only for the duration of the declaration, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. The administration of bamlanivimab and etesevimab together remains investigational and has not been approved under a Biologics License Application (BLA). Evaluation of its safety and efficacy is ongoing in clinical trials. Data from these studies will be used to support a future BLA submission for the treatment.
Bamlanivimab alone is authorized in numerous countries, while bamlanivimab and etesevimab together is currently authorized in the U.S. and Italy. Lilly will continue working with global regulators to make these therapies available around the world. In an effort to help as many patients as possible, Lilly will continue to supply bamlanivimab alone under the authorizations granted in various countries while continuing to accelerate manufacturing of etesevimab for use around the world. Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter.
"As COVID-19 cases, hospitalizations and subsequent deaths continue to rise, we are committed to working with the U.S. government to supply our antibody therapies for use by patients across the country," Skovronsky added.
Lilly anticipates procurement and allocation of bamlanivimab and etesevimab together will mirror the process followed for bamlanivimab alone – making the therapy available directly to governments for allocation based on unmet needs. Global allocation will be made based on Lilly's guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.
For more information about the use of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 in high-risk patients under the FDA's emergency use authorization, contact Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can visit covid.infusioncenter.org or the HHS Therapeutics Distribution locator to find a potential treatment location.
For media resources, including product images and fact sheets, please click here.
Important Information about bamlanivimab alone and bamlanivimab and etesevimab together
Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and bamlanivimab alone and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab and etesevimab together. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab alone.
Authorized Use and Important Safety Information
Limitations of Authorized Use
Important Safety Information
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
Infusion-related reactions have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:
If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.
Clinical Worsening After Bamlanivimab Administration
Limitations of Benefit and Potential Risk in Patients with Severe COVID-19
Based on Phase 3 data from BLAZE-1, the most common adverse events were nausea, dizziness, and rash. These events each occurred in 1% of subjects treated with bamlanivimab and etesevimab together and in 1% of placebo subjects.
Use in Specific Populations
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.
In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), bamlanivimab 2800 mg plus etesevimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.
In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV-2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll up to 3,300 participants.
The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
About Lilly's COVID-19 Efforts
About Eli Lilly and Company
Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) alone or bamlanivimab and etesevimab (LY-CoV016) together as potential treatments for patients with COVID-19, as well as its supply, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or bamlanivimab and etesevimab together will prove to be safe and effective treatments or successful preventative therapies for COVID-19, that bamlanivimab alone or bamlanivimab and etesevimab together will receive regulatory approvals or additional authorizations, or that Lilly can provide an adequate supply of bamlanivimab alone or bamlanivimab and etesevimab together in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
PP-LI-US-0373 02/2021 ©Lilly USA, LLC 2021. All rights reserved.
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