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Lilly's COVID-19 Antibody Drug Gets FDA Emergency Use Authorization For Non-hospitalized Patients

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The U.S. Food and Drug Administration has granted emergency use authorization for Eli Lilly and Co's (LLY) investigational monoclonal antibody therapy bamlanivimab or LY-CoV555 for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients 12 years and older.

The authorization was based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with the investigational neutralizing antibody bamlanivimab or LY-CoV555 700 mg showed reduced viral load and rates of symptoms and hospitalization, the company said in a statement.

LY-CoV555 is now authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

The FDA said that LY-CoV555 is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. The drug has not shown any benefit in the hospitalized patients and could worsen their clinical outcomes.

Lilly said it will begin shipping the COVID-19 antibody drug immediately to AmerisourceBergen, a national distributor, which will distribute it as directed by the U.S. government's allocation program.

Lilly anticipates manufacturing up to one million doses of LY-CoV555 by the end of 2020, for use around the world through early next year. It expects to increase supply of its antibody therapy substantially starting from the first-quarter 2021.

Lilly said it is in discussions with global regulators to make LY-CoV555 available around the world.

Earlier today, Pfizer Inc. (PFE) and German biotech firm BioNTech SE (BNTX) said that their coronavirus vaccine candidate, BNT162b2, was found to be more than 90 percent effective in preventing COVID-19 among patients without prior evidence of infection.

The companies plan to submit for emergency use authorization to the FDA after accumulating two months of safety data, which is expected to be available by the third week of November.

The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

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