COVID-19 Treatment Plans Large Study in October
Indiana-based Eli Lilly announced on October 7, 2020, that it had submitted a request for emergency use authorization (EUA) for the LY-CoV555 monotherapy to U.S. FDA. Lilly made this EUA request based on new data that shows the combination therapy met primary and secondary endpoints, reducing viral load, symptoms, and hospitalizations.
Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, stated in a press release: "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."
Lilly also stated it 'plans to initiate a large open-label pragmatic study in COVID-19 outpatients in October 2020.'