FDA has indicated Lilly‘s OLUMIANT (baricitinib) to treat adult patients with moderately to severely active rheumatoid arthritis. In particular, the agency has recommended the drug for patients with an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
In June, Lilly and its partner Incyte announced that the drug appeared to reduce pain, morning joint stiffness and overall physical function in post-hoc analyses comparing it to Humira and placebo.
Lilly and Incyte are working to expand the indication for the drug. FDA recently delayed the PDUFA action data for a supplemental new drug application for Olumiant for severe atopic dermatitis.
FDA has also granted an emergency use authorization to the drug in combination with remdesivir to treat COVID-19 in hospitalized patients.
Filed Under: Rheumatology