Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA); this was followed shortly after by an approval in Japan in July of the same year. Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.
The FDA approved the 2mg formulation of once-daily, orally administered baricitinib to be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs. Use of the agent in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (bDMARDs), or potent immunosuppressants is not recommended.
This US approval was supported by data from the phase III RA-BEACON study.
Christi Shaw, president, Lilly Bio-Medicines said, “We are pleased to provide RA patients in the U.S. 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.”
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