FDA Approves Baricitinib for Moderate-to-Severe Rheumatoid Arthritis

FDA officials' approval of baricitinib (Olumiant), a 2-mg dose, once-daily oral drug for adults with moderately-to-severely active rheumatoid arthritis (RA) who had an inadequate response to 1 or more tumor necrosis factor (TNF) inhibitor therapies, was recently announced.

Baricitinib is indicated for use as a monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Baricitinib is not recommended for use in combination with other Janus kinase (JAK) inhibitors or biologic DMARDs, or with immunosuppressants such as azathioprine and cyclosporine, according to a press release.

“We are pleased to provide RA patients in the US an effective treatment option with Olumiant, as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult to treat RA patients,” Christi Shaw, president, Lilly Bio-Medicines, said in a press release.

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