Eli Lilly’s Anti-Inflammatory Drug for Arthritis Helps Hospitalized COVID-19 Patients Recover Faster

Initial data from clinical trials have revealed that baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery of hospitalized COVID-19 patients in comparison with remdesivir.

Baricitinib, a JAK1/JAK2 inhibitor licensed to Eli Lilly and Company (Indianapolis, Ind, USA) from Incyte (Wilmington, DE, USA) and marketed as OLUMIANT, is approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA). The initial data was from the Adaptive COVID-19 Treatment Trial (ACTT-2) to assess the efficacy and safety of a 4-mg dose of baricitinib plus remdesivir versus remdesivir in hospitalized patients with COVID-19. ACTT-2, which is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), included more than 1,000 patients. Study investigators noted an approximately one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir versus those treated with remdesivir. The study also met a key secondary endpoint comparing patient outcomes at Day 15 using an ordinal 8-point scale ranging from fully recovered to death. Additional analyses are ongoing to understand other clinical outcome data, including mortality and safety data.

Based on the ACTT-2 data, Lilly plans to discuss the potential for emergency use authorization (EUA) with the US Food and Drug Administration (FDA) and to explore similar measures with other regulatory agencies for baricitinib as a treatment of hospitalized patients with COVID-19. If authorized for use, Lilly will propose that baricitinib be available through commercial channels and will work with hospitals and governments to ensure patient access. Lilly will review the ACTT-2 data with NIAID and assess any impact on COV-BARRIER, the Phase 3 randomized, double-blind, placebo-controlled study it initiated in June to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19 in the US, Europe, Asia and Latin America.

"We are pleased with these data from the ACTT-2 study," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib's role moving forward. We appreciate NIAID selecting baricitinib for inclusion in this important study and the participants, investigators and collaborators for the vital roles they played."

"As a company, we've moved quickly to develop and evaluate medicines for patients for the prevention and treatment of COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly senior vice president and chief scientific officer. "These data allow us to better understand baricitinib's role in potentially improving outcomes for hospitalized COVID-19 patients, and we look forward to continuing this research alongside our other initiatives to combat COVID-19."

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