The drugmaker said it plans to discuss the potential for an emergency use authorization with the FDA for Olumiant as a treatment for hospitalized COVID-19 patients.
Eli Lilly conducted clinical trials for the drug along with Incyte, a drugmaker based in Alapocas, Del. The study, which began in May, included more than 1,000 patients and was sponsored by the National Institutes of Allergy and Infectious Diseases.
The study defined recovery as a participant being well enough for hospital discharge. Eli Lilly said NIAID is expected to publish full details of the study in a peer-reviewed journal.
If Olumiant is authorized for use, Eli Lilly said it will propose that it be available through commercial channels and said it will work with hospitals and governments to ensure patient access. The drugmaker said it will make sure to make an adequate supply of the drug for both COVID-19 patients and rheumatoid arthritis patients.
The U.S. prescribing information for Olumiant for rheumatoid arthritis includes a boxed warning regarding a risk for developing blood clots and serious infections. The New York Times reported in April that the drug would be tested on patients with COVID-19 despite its warning label saying it can make infections worse.
Though the drug can make infections worse, it suppresses the immune system, which suggests it could suppress a cytokine storm, an immune system overreaction seen in some severely ill COVID-19 patients.
Executives at Eli Lilly told the Times in April they were skeptical about the drug’s use to treat COVID-19.
“Our initial reaction was, ‘Does it make sense to immunosuppress when patients are trying to fight off an infection?'” Dan Skovronsky, MD, PhD, chief scientific officer at Eli Lilly, told the Times.
The study results also come just a couple of weeks after Sanofi’s rheumatoid arthritis drug Kevzara failed to treat COVID-19 in early clinical trials.
Read Eli Lilly’s full news release here.
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