FDA to Review Once-Daily Oral RA Tx

The NDA for oral baricitinib has been submitted to the FDA
The NDA for oral baricitinib has been submitted to the FDA

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.

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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.