Eli Lilly's Antibody Treatment For COVID-19 Gets FDA Emergency Use Authorization, , on November 10, 2020 at 3:36 am

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On November 10, 2020
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The United States Food and Drug Administration has issued an emergency use authorization for Eli Lilly and Company’s (NYSE: LLY) monoclonal antibody treatment bamlanivimab for use against COVID-19 in both adults and children.What Happened: Under the EUA, the treatment can be distributed and administered intravenously in a single dose by health care providers, according to a statement issued by the FDA.The authorization was given based on data from two Phase 2 trials in 465 non-hospitalized adults showing mild-to-moderate symptoms of COVID-19.The investigational drug is authorized for high-risk patients, including those aged 65 or above, that test positive for SARS-COV-2, as per the FDA.”This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic, said Eli Lilly CEO David Ricks.Why It Matters: The drug is not authorized for hospitalized patients or for those that require oxygen therapy due to the disease, according to the FDA.Last month, a study by the National Institute of Allergy and Infectious Diseases had found the Eli Lilly antibody drug unhelpful for hospitalized COVID-19 patients.The U.S. government has purchased 300,000 doses of bamlanivimab and Americans will be given these doses free of charge — although hospitals may charge a fee for administration of the therapy, as per Eli Lilly.The Indianapolis, Indiana-based drugmaker said it will begin shipping bamlanivimab to AmerisourceBergen Corp. (NYSE: ABC), which will distribute the drug as per a government allocation program.Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has also applied for a EUA for its investigational COVID-19 antibody cocktail treatment.Meanwhile, Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) emerged as the first to release interim results of large-scale clinical trials of a COVID-19 vaccine candidate, indicating a 90% efficacy.Price Action: Eli Lilly shares traded nearly 3.1% higher in the after-hours at $146.73 on Monday after closing the regular session almost 0.3% lower.Photo courtesy: WikimediaSee more from Benzinga * Click here for options trades from Benzinga * Regeneron Says COVID-19 Antibody Cocktail Reduced Viral Load, Need For Medical Care In Late-Stage Trial * NIAID Study Finds Eli Lilly’s Antibody Drug Unhelpful For Hospitalized COVID-19 Patients(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.,

Eli Lilly's Antibody Treatment For COVID-19 Gets FDA Emergency Use AuthorizationThe United States Food and Drug Administration has issued an emergency use authorization for Eli Lilly and Company’s (NYSE: LLY) monoclonal antibody treatment bamlanivimab for use against COVID-19 in both adults and children.What Happened: Under the EUA, the treatment can be distributed and administered intravenously in a single dose by health care providers, according to a statement issued by the FDA.The authorization was given based on data from two Phase 2 trials in 465 non-hospitalized adults showing mild-to-moderate symptoms of COVID-19.The investigational drug is authorized for high-risk patients, including those aged 65 or above, that test positive for SARS-COV-2, as per the FDA.”This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic, said Eli Lilly CEO David Ricks.Why It Matters: The drug is not authorized for hospitalized patients or for those that require oxygen therapy due to the disease, according to the FDA.Last month, a study by the National Institute of Allergy and Infectious Diseases had found the Eli Lilly antibody drug unhelpful for hospitalized COVID-19 patients.The U.S. government has purchased 300,000 doses of bamlanivimab and Americans will be given these doses free of charge — although hospitals may charge a fee for administration of the therapy, as per Eli Lilly.The Indianapolis, Indiana-based drugmaker said it will begin shipping bamlanivimab to AmerisourceBergen Corp. (NYSE: ABC), which will distribute the drug as per a government allocation program.Regeneron Pharmaceuticals Inc (NASDAQ: REGN) has also applied for a EUA for its investigational COVID-19 antibody cocktail treatment.Meanwhile, Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) emerged as the first to release interim results of large-scale clinical trials of a COVID-19 vaccine candidate, indicating a 90% efficacy.Price Action: Eli Lilly shares traded nearly 3.1% higher in the after-hours at $146.73 on Monday after closing the regular session almost 0.3% lower.Photo courtesy: WikimediaSee more from Benzinga * Click here for options trades from Benzinga * Regeneron Says COVID-19 Antibody Cocktail Reduced Viral Load, Need For Medical Care In Late-Stage Trial * NIAID Study Finds Eli Lilly’s Antibody Drug Unhelpful For Hospitalized COVID-19 Patients(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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