European Commission approves Olumiant (baricitinib) to treat moderate-to-severe active rheumatoid arthritis.- Eli Lilly and Company and Incyte Corporation.

Eli Lilly and Company and Incyte Corporation announced that the European Commission has granted marketing authorisation for Olumiant (baricitinib) 4 mg and 2 mg film-coated tablets in Europe for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

In clinical studies, Olumiant has demonstrated significant improvement in the signs and symptoms of RA compared to standard of care therapies such as methotrexate and Humira (adalimumab) with background methotrexate. Baricitinib's phase III program includes four completed clinical studies in a wide range of adult patients with RA, from treatment-naïve patients to those who are inadequate responders to TNF inhibitors. Two of those studies, RA-BEGIN and RA-BEAM, included a pre-specified comparison against either methotrexate or Humira with background methotrexate. Patients completing any of the phase III studies could enroll in a long-term extension study.

Comment: This is the first regulatory approval around the world for Olumiant -- the first JAK inhibitor approved to treat RA in the European Union -- which may be used as monotherapy or in combination with methotrexate.