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

  • 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.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAGeneralBriefsrheumatoid arthritis
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!