July 28, 2021
The U.S. FDA has expanded the scope of Emergency Use Authorization (EUA) for Olumiant (baricitinib – Eli Lilly) to allow it to be used alone to treat COVID-19. The drug is authorized for use in hospitalized patients at least two years of age who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Previously, the EUA required that Olumiant be used with Veklury® (remdesivir – Gilead).
In a clinical trial, the Olumiant treatment arm saw a reduction in proportion of patients who died through 28 days of follow-up compared to patients who received standard of care for COVID-19. Most patients in the study did not receive Veklury. However, the study raised no questions about the safety of using Olumiant and Veklury together to treat COVID-19, and the EUA still allows for their combined use in treating patients ages two years and up who are hospitalized with COVID-19 and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Veklury is FDA-approved to treat COVID-19 in individuals who are at least 12 years old, weigh at least 40kg (88 pounds), and require hospitalization. Veklury also has an EUA to treat hospitalized pediatric patients who weigh 3.5kg (7.7 pounds) to less than 40kg or who are less than 12 years old and weigh at least 3.5kg.