FDA issues EUA for Lilly's JAK inhibitor plus remdesivir for COVID-19

By The Science Advisory Board staff writers

November 20, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the drug baricitinib, a janus kinase (JAK) inhibitor, in combination with remdesivir for the treatment of COVID-19 in hospitalized patients.

The approval pertains to suspected or laboratory confirmed cases in hospitalized adults and pediatric patients two years of age or older who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The data supporting the EUA are based on a randomized, double-blind, placebo-controlled Adaptive COVID-19 Treatment Trial (ACTT-2), which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The study demonstrated that in hospitalized patients with COVID-19, baricitinib in combination with remdesivir reduced the recovery time within 29 days after initiating treatment compared to patients who received a placebo with remdesivir.

Baricitinib was discovered by Incyte and licensed to Eli Lilly and works by interfering with the pathway leading to inflammation. The drug is approved for the treatment of adults with moderately to severely active rheumatoid arthritis in the U.S. It is not authorized or approved as a stand-alone treatment for COVID-19.

Remdesivir is an FDA-approved antiviral drug for the treatment of COVID-19 requiring hospitalization.

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