Eli Lilly and Company and Incyte announced that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen.
"These published data from a rigorous, double-blind, placebo-controlled trial are critical in helping the scientific community make better-informed treatment decisions to improve clinical outcomes for patients," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center, a principal investigator of the ACTT studies and lead study author of the ACTT-2 New England Journal of Medicine manuscript. "Results of this study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen."
"Presently, there are limited published placebo-controlled data assessing treatment options to manage the symptoms and progression of COVID-19," said Anabela Cardoso, M.D., an author of the New England Journal of Medicine paper and Lilly global brand development lead, immunology. "We need high-quality research such as the ACTT-2 study to evaluate therapies to fight this pandemic and are pleased that this medicine is now available for patients under EUA."
Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Please see below for important warnings and information about the authorized use of baricitinib in the U.S. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established.
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).
Authorized Use Under the EUA and Important Safety Information for baricitinib (in the United States) for COVID-19
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.
Important Safety Information about baricitinib for COVID-19
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, patien...
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