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Eli Lilly and Incyte say phase 3 study of baricitinib in hospitalized patients with COVID-19 failed to meet primary goal

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Eli Lilly & Co. LLY,
-0.26%
and Incyte Corp. INCY,
-2.16%
said Thursday that a phase 3 trial of baricitinib plus standard of care (SoC) versus placebo plus SoC rheumatoid arthritis treatment failed to meet its primary goal. The primary endpoint of the trial was defined as a difference in the number of patients requiring non-invasive ventilation, including high oxygen flow, or invasive mechanical ventilation, or death on day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard care of progression to ventilation or death, a difference that was not statistically significant. The trial, involving 1,525 patients, showed a 38% reduction in mortality at Day 28 in patients treated with baricitinib plus standard care, including corticosteroids and remdesivir. Lilly said she would publish detailed data from the study in a peer-reviewed journal in the coming months. “Although the study did not show a statistically significant benefit on the primary endpoint, this trial showed the most significant effect reported to date for the reduction in mortality observed for this population of patients with the disease. COVID-19, “said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. The United States Food and Drug Administration has granted authorization for the emergency use of baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal oxygenation by membrane. Baricitinib, an oral inhibitor of JAK, was discovered by Incyte. It is approved as Olumiant in the United States as a treatment for adults with moderate to severe rheumatoid arthritis and in the EU and Japan as a treatment for atopic dermatitis. Lilly shares were up 0.4% pre-market, while Incyte was up 2%.

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