Lilly applies for emergency use of COVID-19 single antibody treatment

By Manas Mishra

(Reuters) – Eli Lilly and Co <LLY.N> is seeking emergency use authorization from the U.S. health regulator for its experimental COVID-19 antibody monotherapy and plans to pursue a similar approval for a combination therapy with two of its antibody drugs next month.

The drugmaker on Wednesday reported positive data from a mid-stage trial testing its combination antibody therapy, which helped cut hospitalization and emergency room visits for COVID-19 patients.

The data was in line with results from a September trial testing its single antibody treatment LY-CoV555.

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 Pharmaceuticals Inc <REGN.O> 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 a combination of Lilly’s two antibody treatments had to be hospitalized, compared with 5.8% on a placebo.

The combination therapy also met the trial’s main goal of significantly reducing the virus load 11 days after treatment, compared with a placebo, Lilly said. The treatment also reduced viral levels at day three and day seven.

“We believe that Lilly’s data provides some real evidence that the combo mAb (monoclonal antibody) approach may provide meaningful clinical benefits,” Baird analyst Brian Skorney said.

The company expects 100,000 doses of LY-CoV555 to be available in October and about one million in the fourth quarter. Lilly expects to supply 50,000 doses of the combination therapy in the fourth quarter.

The company’s shares were up 2% in morning trading.

(Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila and Shounak Dasgupta)

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