Lilly and Incyte Receive FDA Authorization for Baricitinib as Monotherapy for Hospitalized COVID-19 Patients

On July 29 local time, the U.S. FDA expanded the Emergency Use Authorization (EUA) for baricitinib (brand name Olumiant), developed by Eli Lilly (LLY.US) and Incyte Corporation (INCY.US). Under the revised EUA, baricitinib is no longer required to be used in combination with Gilead Sciences' (GILD.US) Veklury (remdesivir) for the treatment of hospitalized patients with confirmed COVID-19.

Prior to this, under FDA authorization, the two drugs were required to be used in combination for the treatment of hospitalized patients with confirmed COVID-19.

It is reported that, under the revised Emergency Use Authorization (EUA), baricitinib may be used alone to treat hospitalized adult and pediatric patients aged 2 years and older with confirmed COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).