FDA Revises Olumiant EUA for Treating COVID-19
The FDA has revised its Emergency Use Authorization (EUA) for Eli Lilly’s and Incyte’s COVID-19 treatment Olumiant (baricitinib) to authorize giving the drug alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years or older requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Previously, Olumiant was authorized only if given with Gilead Sciences’ Veklury (remdesivir). FDA granted the original EUA on Nov. 19, 2020.
Originally approved in the U.S. in 2018 for rheumatoid arthritis, the immunosuppressant works by inhibiting Janus kinase enzymes that cause inflammation and tissue damage seen in severe COVID-19 infections.
The FDA said the EUA revision was supported by data from a clinical trial of hospitalized patients with COVID-19, where Olumiant showed a reduction in the proportion of patients who died through 28 days of follow-up compared to patients treated with the standard of care for COVID-19.