FDA to Review Once-Daily Oral RA Tx
Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
The NDA submission is supported by data from four pivotal Phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis. The baricitinib clinical trial program includes a wide range of patients including those who are disease-modifying anti-rheumatic drugs (DMARD) naïve, inadequate responders to methotrexate, inadequate responders to conventional DMARDs, or inadequate responders to biologic DMARDs. Patients who have completed any of the Phase 3 studies can enroll in a long-term extension study.
Baricitinib is currently being evaluated in an ongoing Phase 3 trial for RA and Phase 2 development for psoriasis, diabetic nephropathy, atopic dermatitis and systemic lupus erythematosus.
Baricitinib is the only once-daily oral selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases.
For more information call (800) 545-5979 or visit Lilly.com.