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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.

Go to Publication

References: 1. Baricitinib. Fact Sheet for Healthcare Providers. Lilly USA, LLC; 2020. 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.

AUTHORIZED USE

Baricitinib is authorized for use under an Emergency Use Authorization (EUA) 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).

  • Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.
  • Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA 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.

Under the EUA, baricitinib is available as 1 mg and 2 mg tablets.

IMPORTANT SAFETY INFORMATION

The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization.

WARNINGS

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.

Abnormal Laboratory Values: Evaluate estimated glomerular filtration rate (eGFR), liver enzymes, and complete blood count at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines.

Vaccinations: Avoid use of live vaccines with baricitinib.

Hypersensitivity: If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction.

See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib.

Serious Side Effects: Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib.

There are limited clinical data available for baricitinib use in COVID-19. Additional safety information regarding baricitinib may be found in the full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

USE IN SPECIFIC POPULATIONS

Pregnancy: Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.

Renal Impairment: There are limited data for baricitinib in patients with severe renal impairment. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury.

Hepatic Impairment: Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk.

Please see Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish).

BC HCP EUA ISI 19NOV2020

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