The United States Food and Drug Administration has issued an emergency use authorization for Eli Lilly and Company’s 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. ABC, which will distribute the drug as per a government allocation program.
Regeneron Pharmaceuticals Inc REGN has also applied for a EUA for its investigational COVID-19 antibody cocktail treatment.
Meanwhile, Pfizer Inc PFE and BioNTech SE 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.
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