Baricitinib Receives FDA Emergency Use Authorization for Treatment of Hospitalized COVID-19 Patients in Combination with Remdesivir

On November 19, Eli Lilly and Incyte announced that the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for the combination therapy of baricitinib and remdesivir. The authorization permits the emergency use of this combination therapy in hospitalized adult and pediatric patients (aged 2 years and older) with suspected or confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Eli Lilly, has previously been approved in the United States for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) and atopic dermatitis.

The EUA is based on data from the adaptive Phase 3 ACTT-2 clinical trial, a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo in combination with remdesivir in hospitalized patients with COVID-19. The trial results demonstrated that, compared to the remdesivir plus placebo group, the median time to recovery was significantly reduced from 8 days to 7 days in patients receiving baricitinib plus remdesivir, representing a 12.5% improvement (HR: 1.15; 95% CI 1.00–1.31; p=0.047). Patients in the combination therapy group were more likely to have improved clinical status by day 15 (HR: 1.26; 95% CI 1.01–1.57; p=0.044). By day 29, a lower proportion of patients in the combination therapy group progressed to mechanical ventilation (non-invasive or invasive) or death (HR: 0.74; 95% CI 0.56–0.99; p=0.039). The mortality rate by day 29 was 4.7% in the combination therapy group compared to 7.1% in the remdesivir plus placebo group, representing a 35% relative reduction.

This is the first COVID-19 combination therapy regimen granted Emergency Use Authorization (EUA) by the FDA. Baricitinib has not yet received FDA approval for the indication of treating COVID-19; its efficacy and safety as a treatment for COVID-19 are currently being evaluated in clinical trials.

References:

[1] Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19. Retrieved 2020-11-20, from https://www.prnewswire.com/news-releases/baricitinib-receives-emergency-use-authorization-from-the-fda-for-the-treatment-of-hospitalized-patients-with-covid-19-301177712.html

Source: Jike Yaowen

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