Sunday, April 18, 2021

Eli Lilly’s COVID-19 drug gets U.S. authorization

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Eli Lilly’s combination antibody therapy to fight COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration, Lilly said on Tuesday. Gloria Tso reports.

Eli Lilly’s combination antibody therapy to fight COVID-19 has been granted emergency use authorization in the United States.

The company announced Tuesday its antibody drug had been authorized by the U.S. Food and Drug Administration, after data from a late-stage trial in January showed it helped cut the risk of hospitalization and death in COVID-19 patients by 70%.

Eli Lilly’s therapy combines two antibodies, bamlanivimab and etesevimab, and is similar to the experimental medication touted by former U.S. President Donald Trump after he was hospitalized with COVID-19 last October.

In a statement, the company said the therapy was authorized for the treatment of quote “mild to moderate COVID-19 in patients aged 12 or older who are at high risk for progressing to severe COVID-19 and/or hospitalization.”

But the FDA said the drug would not be authorized for patients who are already hospitalized due to COVID-19 or require oxygen therapy.

Eli Lilly added that 100,000 doses would be ready immediately and an additional 150,000 doses would be available throughout the first quarter.

The company says they plan to manufacture up to 1 million doses by mid-2021, in collaboration with American biotech company Amgen.

Last November, the FDA approved Eli Lilly’s single-antibody treatment.

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