Skip to main content

Olumiant (Baricitinib) and Actemra (Tocilizumab) & Emergency Use Authorization (EUA) Utilization

    Basic Details
    Last Updated
    Thursday, February 15, 2024
    Original Posting Date
    Health Outcome(s)
    emergency use authorization (EUA) utilization
    Other Regulatory
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In November 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for baricitinib to be used in combination with remdesivir to treat COVID-19 in hospitalized patients on respiratory support (i.e., supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation). In June 2021, the FDA issued an EUA for tocilizumab to treat COVID-19 in hospitalized patients receiving systemic corticosteroids and on respiratory support. To understand the scope of utilization and characteristics of users of baricitinib and tocilizumab in the context of COVID-19, FDA conducted a descriptive analysis among patients with inpatient baricitinib or tocilizumab use in the Sentinel System. Both products were commercially available prior to FDA issuance of the EUAs, and the study period for this analysis (April 1, 2020, to March 31, 2021) included time prior to FDA issuance of these EUAs. Specific characteristics assessed included evidence of COVID-19, use of respiratory support, concomitant drug use, and medical conditions.

    Results indicated that most patients who received inpatient baricitinib/remdesivir therapy had evidence of COVID-19. However, about half of patients who received inpatient baricitinib therapy did not appear to have concurrent remdesivir use, and few patients with inpatient baricitinib therapy appeared to have documented respiratory support at drug therapy initiation. Results also indicated that most patients with inpatient tocilizumab therapy had evidence of COVID-19 and a majority had concurrent systemic corticosteroid therapy. Additionally, around 25% of patients with tocilizumab therapy had documented mechanical ventilation at drug therapy initiation.  This analysis informed the FDA’s active safety monitoring efforts for products authorized or used for the treatment of COVID-19. FDA approved these products for the treatment of adults with COVID-19 in May 2022 (baricitinib) and December 2022 (tocilizumab), and EUAs remain in place for use in pediatric patients as of August 2023.