Eli Lilly has asked the Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for an experimental antibody treatment for COVID-19 that they say has been shown to reduce viral load, symptoms and hospitalizations in patients diagnosed with mild-to-moderate cases of coronavirus.
The drug, LY-CoV555, is derived from a blood sample taken from one of the first U.S. patients who recovered from a COVID-19 infection. The company said in a news release it could have as many as 100,000 doses by the end of October, and up to 1 million by next year.
The drug is also being tested in a combination therapy trial, which has also shown success, according to the company. However, the EUA request specifically seeks approval for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.
“Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments,” said Dr. Daniel Skovronsky, the company’s chief scientific officer and president of Lilly Research Laboratories. “We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available.”
The news release noted that the drug is also being tested in two National Institutes of Health (NIH)-led studies, but that the trials are ongoing. The company said it expects to submit an EUA request for its combination therapy as early as November pending clinical trial enrollment.