Eli Lilly’s Antibody Combination Gets FDA Emergency Use Authorization

Feb 9 (Reuters) – 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.
Lilly’s combination therapy of two antibodies, bamlanivimab and etesevimab, helped cut the risk of hospitalization and death in COVID-19 patients by 70%, data from a late-stage trial showed in January.
Lilly said the therapy will be available immediately.
“There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter,” Lilly said in a statement.
The company said that in collaboration with Amgen, it plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021.
Lilly said the “therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.”
The FDA, separately, said bamlanivimab and etesevimab are not authorized for patients hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19.
Late last month, Lilly reported a fourth-quarter profit that topped Wall Street estimates. It recorded $871.2 million in quarterly sales of the COVID-19 therapy bamlanivimab, benefiting from the U.S. government’s move to stock up on the drug for emergency use
via thefederalistpapers

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