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Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19
SHANGHAI, China, Feb. 10, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational etesevimab (JS016 or LY-CoV016) 1400 mg and bamlanivimab (LY-CoV555) 700 mg together, according to the company’s global partner Eli Lilly and Company (NYSE: LLY). 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. Etesevimab and bamlanivimab 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 change has been made in response to feedback received from front-line nurses and doctors administering these infusions and is aimed at reducing the burden on the healthcare system. The EUA is based on Phase 3 data from the BLAZE-1 trial, announced on January 26, 2021, which demonstrated that etesevimab and bamlanivimab 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 (IF=45.54), in a much larger group of patients. The most common adverse event more often reported for patients receiving etesevimab and bamlanivimab 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 etesevimab and bamlanivimab together, data demonstrated consistent and similar clinical effects among all doses studied. Additionally, initial results from an ongoing Phase 2 study provided viral load and pharmacodynamic/pharmacokinetic data which demonstrated etesevimab 1400 mg and bamlanivimab 700 mg together produced similar effects to those observed in the Phase 3 trial with etesevimab 2800 and bamlanivimab 2800 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 etesevimab and bamlanivimab 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 etesevimab and bamlanivimab 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 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. Lilly anticipates procurement and allocation of etesevimab and bamlanivimab 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 aim to ensure access for patients with high unmet need, no matter where they live. Dr. Ning LI, CEO of Junshi Biosciences said: “Since the outbreak of the pandemic, Junshi Biosciences and the IMCAS have been dedicated to the co-development of neutralizing antibodies. Now, with Lilly, our global partner’s participation, the innovative therapy is authorized for use in the U.S. and Italy, while unremitting endeavors to meet the extensive anti-COVID-19 needs are made by the local and oversea medical industry. The data of etesevimab and bamlanivimab together provides strong evidence for the safety and efficacy of JS016, thus giving us confidence to proceed with the clinical trial of JS016, which is ongoing in several countries and regions, including Mainland China, Hong Kong, the Philippines, etc." About etesevimab(JS016) 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. About bamlanivimab(LY-CoV555) 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. About BLAZE-1 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), etesevimab 2800 mg plus bamlanivimab 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 etesevimab 2800 mg plus bamlanivimab 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. About BLAZE-4 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 Junshi Biosciences About Eli Lilly and Company Contact Information IR Team: Solebury Trout PR Team: |