Eli Lilly-Incyte's Rheumatoid Arthritis Drug Gets OK From FDA For Solo Use In Hospitalized COVID-19 Patients

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  • The FDA extended the Emergency Use Authorization (EUA) for Eli Lilly And Co's LLY and Incyte Corporation's INCY rheumatoid arthritis drug Olumiant (baricitinib) to be used as a sole treatment for hospitalized COVID-19 patients who need supplemental oxygen.
  • The oral drug was previously cleared in conjunction with Gilead Sciences Inc GILD remdesivir.
  • In a Phase 3 study reported in April, Olumiant did not meet its primary endpoint. The drug failed to reach statistical significance for the difference in the rate of patients needing non-invasive or invasive ventilation for the first time or those who died after four weeks. 
  • But FDA said that the revised EUA for baricitinib was supported by data from that study, which showed a reduction in the proportion of patients who died after four weeks of follow-up compared to patients treated with the standard of care alone.
  • Price Action: LLY shares are down 0.57% at 245.10, INCY shares are down 0.37% at $77.72 during the market session on the last check Thursday.
  • Related content: Benzinga's Full FDA Calendar.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsrheumatoid arthritis
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