Results Published Supporting an Emergency Use Authorization for COVID-19
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of baricitinib, in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is supported by data from the Adaptive COVID-19 Treatment Trial 2 (ACTT-2), a double-blind, placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).1
Baricitinib has not been approved for the treatment of coronavirus disease 2019 (COVID-19), but has been authorized for emergency use by the FDA.
Baricitinib is authorized under an Emergency Use Authorization (EUA) only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English; Spanish).
Under the EUA, baricitinib is available as 1 mg and 2 mg tablets.
The New England Journal of Medicine published the results of ACTT-2.2
Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. New Engl J Med. 2020; doi: 10.1056/NEJMoa2031994.
Please see below for a link to the publication.
SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS AND THROMBOSIS
Serious Infections: Serious infections have occurred in patients receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis. Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections.
Thrombosis: In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately.
Please note that there is information in the New England Journal of Medicine publication that is not contained in or differs from the information contained in the Fact Sheet for Healthcare Providers for baricitinib. The following highlights some important differences.
Fact Sheet for Healthcare Providers
Summarizes results on time to recovery, clinical status at Day 15, progression to death or noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29, and mortality by Day 29 for the overall population (baseline ordinal scale score 4 to 7).
Analyses of time to recovery, progression to death or noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation, and mortality outcomes stratified patients by baseline severity entered at the time of randomization.
The New England Journal of Medicine Publication
Includes results on endpoints presented in the Fact Sheet at additional timepoints and by baseline ordinal scale score.
Includes additional secondary outcomes related to recovery, change in ordinal scale scores, hospitalization, and use of oxygen, noninvasive ventilation/high-flow oxygen, and mechanical ventilation/ECMO.
Analyses of time to recovery, progression to death or noninvasive ventilation/high-flow oxygen or invasive mechanical ventilation, and mortality outcomes were based on stratification of patients according to actual baseline severity at enrollment, resulting in slight numerical differences in results.