FDA Authorizes New Standalone Treatment for COVID-19

The U.S. 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. 

Under the EUA, fact sheets that provide important information about using baricitinib in treating COVID-19 as authorized must be made available to health care providers and to patients, parents, and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Possible side effects of baricitinib include serious infections, blood clots, changes in certain lab test results and allergic reactions.

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. A contraindication describes when the use of a product is not appropriate.

Remdesivir is approved to treat COVID-19 in hospitalized adults and pediatric patients (12 years of age and older and weighing at least 40 kg) requiring hospitalization. Remdesivir also remains authorized for emergency use for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.