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 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.

Photo courtesy: Wikimedia

Posted In: BiotechNewsFDATop StoriesGeneralAntibodiesBamlanivimabCoronavirusCovid-19