The European Commission ( EC ) 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 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 rheumatoid arthritis 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 rheumatoid arthritis compared to standard of care therapies such as Methotrexate and Adalimumab ( Humira ) with background Methotrexate.
Baricitinib's phase 3 program includes four completed clinical studies in a wide range of adult patients with rheumatoid arthritis, 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 Adalimumab with background Methotrexate.
Patients completing any of the phase 3 studies could enroll in a long-term extension study.
Baricitinib is a once-daily oral, selective and reversible JAK1 and JAK2 inhibitor currently in clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2.
JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions, including rheumatoid arthritis.
Arthritis rheumatoid is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide suffer from rheumatoid arthritis. Approximately three times as many women as men have the disease.
Current treatment of rheumatoid arthritis includes the use of non-steroidal anti-inflammatory drugs, oral conventional synthetic disease-modifying antirheumatic drugs ( csDMARDs ), such as Methotrexate ( the current standard of care ) and injectable, biological disease-modifying antirheumatic drugs ( bDMARDs ) that target selected mediators implicated in the pathogenesis of rheumatoid arthritis.
Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission. ( Xagena )
Source: Eli Lilly, 2017