Eli lilly applies for an fda emergency use authorization for its coronavirus treatment

Eli lilly applies for an fda emergency use authorization for its coronavirus treatment


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Lilly corporate headquarters in Indianapolis, Indiana Source: Eli Lilly Eli Lilly is seeking emergency use authorization from the U.S. Food and Drug Administration for its experimental


Covid-19 antibody treatment and expects to have one million doses available in the fourth quarter, the drugmaker said. The drug, LY-CoV555, which had helped cut hospitalization and emergency


room visits for Covid-19 patients in a trial in September, showed similar results in combination with another antibody treatment from the company in new data reported on Wednesday. Several


drugmakers are testing antibody treatments in Covid-19 patients, looking to prevent symptoms from progressing. None of these drugs are yet authorized for emergency use in the United States,


but an experimental two-antibody combination under development by Regeneron was among the treatments given to U.S. President Donald Trump for his Covid-19 infection. In a total of 268


patients with mild-to-moderate Covid-19, nearly 1% given Lilly's combination therapy had to be hospitalized, compared with 5.8% on a placebo. The combination therapy also met the trial


main goal of significantly reducing the amount of virus 11 days after treatment, compared with a placebo, Lilly said. The treatment also reduced viral levels at day three and day seven.


"On first look, we think the data seem modestly better than the monotherapy data (in September)," said Cantor Fitzgerald analyst Louise Chen. Lilly said it would seek the


FDA's nod for emergency use of the combination therapy in November, once additional safety data is available and enough doses are made. The company expects 100,000 doses of LY-CoV555 to


be available in October and about 50,000 doses of the combination therapy in the fourth quarter this year. Lilly's shares were up 2% in morning trading.