Eli Lilly applies for emergency use of antibody drug for COVID-19

By Manas Mishra and Carl O'Donnell
(Reuters) - Eli Lilly and Co announced on Wednesday that they have applied for a U.S. Emergency Authorization (EUA) for their experimental COVID-19 antibody treatment and intend to apply for similar approval for a double antibody therapy next month after seeing promising data have submitted.
The drug maker said its two-antibody cocktail helped lower virus levels more than treatment with single antibodies in a previous study. The lower viral load may have been linked to a reduction in COVID-19 symptoms, the company said.
"We believe that Lilly's data provides some real evidence that the combo monoclonal antibody (mAb) approach can offer significant clinical benefits," said Brian Skorney, analyst at Baird.
The Indianapolis drug maker’s shares rose more than 3%.
Data in September showed that Lilly's LY-CoV555 single antibody therapy, developed with Canadian biotechnology AbCellera, helped reduce hospital stays and emergency room visits for COVID-19 patients.
Based on this data, Lilly filed for an EEA with the U.S. Food and Drug Administration and expects about one million doses of the biotech drug to be available by the end of the year.
Several drug manufacturers are testing antibody treatments for COVID-19 to help patients' immune systems fight the virus. None of these drugs have been approved for emergency use in the United States.
An experimental double-antibody cocktail developed by Regeneron Pharmaceuticals Inc was among the drugs given to U.S. President Donald Trump to treat his COVID-19. The company supplied the drug through a compassionate consumption program.
Lilly chose not to distribute his experimental drug through a compassionate use program, preferring to recruit patients who are needed for his clinical trials because of the urgent need to generate data to show that it works, said Chief Executive David Ricks on a conference call.
In the study of 268 patients with mild to moderate COVID-19, nearly 1% of those who received Lilly double antibody therapy had to be hospitalized. This indicates a clinically meaningful response compared to 5.8% who received a placebo.
The combination therapy also met the study's main goal of significantly reducing the amount of virus present 11 days after treatment compared to a placebo, Lilly said. The treatment also reduced virus levels on the third and seventh days.
Lilly expects to ship 50,000 doses of combination therapy in the fourth quarter.

(Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta and Bill Berkrot)

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