Emergency Use Authorization (EUA) for the Treatment of 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).
The Secretary of the Department of Health and Human Services has declared a public health emergency that justifies the emergency use of baricitinib to treat coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection. In response, the U.S. Food and Drug Administration (FDA) has issued an EUA for baricitinib for the treatment of COVID-19.
- 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.
- 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.
Additional Information for Healthcare Providers:
- Healthcare Providers should provide a copy of the Fact Sheet for Patients, Parents, and Caregivers to patients and/or caregivers prior to treatment.
- Healthcare Providers and/or their designee are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths occurring during baricitinib treatment and considered to be potentially attributable to baricitinib. These events must be reported within 7 calendar days from the onset of the event.
MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or online here.
Other Reporting Requirements: Report adverse events or medication errors to Lilly at: 1-855-LillyC19 (1-855-545-5921).
ACCESS
Baricitinib is available as 1 mg and 2 mg tablets for use in COVID-19 for inpatient facilities through Lilly’s Authorized Specialty Distributors.
UPDATES
Updates for the baricitinib Emergency Use Authorization for COVID-19, including relevant information and upcoming events, will be communicated as they become available.