Biotech and Pharma

Eli Lilly applies for an FDA emergency use authorization for its coronavirus treatment

Key Points
  • Eli Lilly has submitted a request to the U.S. Food and Drug Administration for emergency use of its experimental Covid-19 antibody treatment, the U.S. drugmaker said.
  • Lilly said its drug, which had helped reduce hospitalization and emergency room visits for Covid-19 clinical trial patients, showed similar results in combination with another of its antibody treatments.
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.