Eli Lilly Antibody Drug Combo For COVID-19 Gets FDA Emergency Approval

Eli Lilly and Co LLY’s antibody treatments have received an emergency use authorization from the United States Food and Drug Administration.

What Happened: The federal regulator issued the EUA for the two drugs, bamlanivimab and etesevimab, to be administered together for the treatment of mild to moderate COVID-19 in both adults and children above 12 years of age.

The treatment is meant for those who test positive for COVID-19 and are at high risk of progressing to a severe version of the disease.  Bamlanivimab, in combination with Gilead Sciences Inc.'s GILD remdesivir, received FDA emergency approval for use in hospitalized patients back in November last year.

The EUA clears the way for the use of the two drugs in those who are 65-years of age or older, or who have chronic medical conditions.

The EUA is based on a clinical trial that established that the two antibody treatments when given together cut the risk of hospitalization and death in COVID-19 patients by 70%, as per the FDA.

Bamlanivimab and etesevimab are not authorized for hospitalized COVID-19 patients or those who require oxygen therapy due to the viral disease. 

Why It Matters: Lilly is partnering with Amgen to make up to one million doses of etesevimab for administration with bamlanivimab by mid-year, the company said in a statement.

One-hundred thousand doses are ready immediately and an additional 150,000 doses would be available through the first quarter.

In December, it was reported that Regeneron Pharmaceuticals Inc REGN antibody cocktail showed positive results in early-stage trials of hospitalized patients. 

See Also: Regeneron To Supply US With Another 1.25M COVID-19 Treatment Doses

Regeneron reported sales of $145.5 million for its REGN-COV antibody cocktail for COVID-19 last week.  

Price Action: Eli Lilly shares closed nearly 2% lower at $201.71 on Tuesday.

Posted In: AntibodiesBamlanivimabCovid-19etesevimabBiotechNewsFDAGeneral

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