FDA News: Issue 29, September 2021

Author: [AUTHOR] Published on 9/10/2021 5:00:00 AM

FDA Authorizes Baricitinib Alone as Treatment for COVID-19

On July 28, 2021, the US Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for baricitinib (sold under the brand name Olumiant) now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered with remdesivir (Veklury). Baricitinib is not FDA-approved as a treatment for COVID-19.

This revision to the EUA for baricitinib was supported by data from a clinical trial of hospitalized patients with COVID-19, where baricitinib showed a reduction in the proportion of patients who died through 28 days of follow-up compared to patients treated with the standard of care for COVID-19 alone. This study did not require baricitinib to be used in combination with remdesivir and most of the patients did not receive remdesivir. This study provided information that was previously unavailable to the agency at the time of the original authorization. 


While this revised EUA no longer requires baricitinib to be administered with remdesivir, the Agency’s letter of authorization notes that the COV-BARRIER trial supporting this revision did not raise questions about the safety or efficacy of baricitinib when used in combination with remdesivir for the treatment of patients hospitalized due to COVID-19 requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The use of baricitinib in combination with remdesivir is not contraindicated under the terms and conditions of this authorization.

The updated Fact Sheet for Health Care Providers provides essential information about using baricitinib in treating COVID-19 as authorized and is available at https://go.usa.gov/xFuMm. An updated fact sheet for patients, parents, and caregivers is available at https://go.usa.gov/xF5Kr. These fact sheets include dosing instructions, potential side effects, and drug interactions. Additional information is available in the Frequently Asked Questions on the Emergency Use Authorization of Baricitinib for Treatment of COVID-19 document at https://go.usa.gov/xF5K2.

Additional Information
The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. For additional information on the EUA authority and EUAs for COVID-19, please visit https://go.usa.gov/xs8x4.

To promote public confidence in FDA’s scientific review process and in ultimately appropriately using products authorized for emergency use, FDA’s Center for Drug Evaluation and Research (CDER) recently launched a new webpage to facilitate access to information from CDER’s scientific review documents supporting EUAs for drug and biological therapeutic products that the Agency has disclosed. This webpage compiles the scientific review documents supporting EUAs for COVID-19 drug and biological therapeutic products that the Agency has disclosed into one location to make documents easier to find and can be accessed at https://go.usa.gov/xsHzW.


The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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