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Eli Lilly's Antibody Treatment For COVID-19 Gets FDA Emergency Use Authorization

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Eli Lilly's Antibody Treatment For COVID-19 Gets FDA Emergency Use Authorization

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: Wikimedia

 

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