EC Approves Once-Daily Olumiant Tablets to Treat Adults with Moderate-to-Severe Active RA

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).

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. 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.

“Despite clinical advances in treatment, many people with RA continue to struggle with the debilitating effects of this disease, which can lead to long-term joint damage and disability,” said J. Anthony Ware, M.D., senior vice president for product development and interim president, Lilly Bio-Medicines. “We believe that as a next-generation therapy in the EU, Olumiant will advance RA treatment by helping patients with moderate-to-severe disease feel better quickly.”

Baricitinib’s phase 3 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 3 studies could enroll in a long-term extension study.

“The European Commission’s approval of baricitinib is an exciting milestone for the RA community in the EU,” said Steven Stein, M.D., chief medical officer, Incyte Corporation. “We’re confident that baricitinib will help to meet the needs of healthcare providers and their patients as they work toward achieving long-term treatment goals.”

As a result of the approval of Olumiant by the European Commission, Incyte becomes eligible to receive a milestone payment of $65 million from Lilly, which it expects to record in full in the first quarter of 2017.