INDIANAPOLIS — The U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization for Eli Lilly's anti-inflammatory drug baricitinib used to treat COVID-19.
The treatment can now be used on its own, when previously it had to be used in conjunction with remdesivir. Previously, the FDA said the drug combination appeared to reduce recovery time in hospitalized patients, compared to patients who received only remdesivir.
The expanded Emergency Use Authorization allows baricitinib to be used for treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
“Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use,” said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. “Today’s FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic. Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen.”
Indianapolis-based Lilly already sells baricitinib as Olumiant to treat rheumatoid arthritis, the less common form of arthritis that occurs when the immune system attacks joints, causing inflammation. An overactive immune system also can lead to serious problems in coronavirus patients.