FDA authorizes baricitinib alone as treatment for COVID-19

The US Food and Drug Administration has revised the Emergency Use Authorization (EUA) for baricitinib, sold under the brand name Olumiant by Eli Lilly’s (NYSE: LLY), now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Under the revised EUA, baricitinib is no longer required to be administered with remdesivir, marketed by Gilead Sciences (Nasdaq: GILD) as Veklury. Baricitinib is not FDA-approved as a treatment for COVID-19.

This revision to the EUA for baricitinib was supported by data from a clinical trial of hospitalized patients with COVID-19, where baricitinib 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 alone. This study did not require baricitinib to be used in combination with remdesivir and most of the patients did not receive remdesivir. This study provided information that was previously unavailable to the agency at the time of the original authorization.