Indianapolis-based Eli Lilly and Co. (NYSE: LLY) says the U.S. Food and Drug Administration has broadened the Emergency Use Authorization for baricitinib to allow for treatment of COVID-19 with or without remdesivir. The previous EUA was previously restricted to use only in combination with remdesivir, a drug produced by California-based Gilead Sciences Inc. (Nasdaq: GILD).
Lilly says the EUA provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen. The company says the revised authorization gives physicians greater flexibility in how they can address the urgent medical needs posed by the pandemic.
“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. “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.”
Lilly says the authorization is temporary and does not replace the formal review and approval process. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19. It does, however, have FDA approval as a treatment for rheumatoid arthritis under the brand name Olumiant.