Japan Ministry of Health, Labor and Welfare (MHLW) Grants Marketing Approval For Olumiant® (baricitinib) for the Treatment of Rheumatoid Arthritis
The Olumiant approval is based on the results of the baricitinib development program, which includes four phase 3 clinical trials enrolling various populations of more than 3,000 moderate-to-severe RA patients worldwide, including more than 500 Japanese patients. In clinical studies, baricitinib has demonstrated significant improvement in the signs and symptoms of RA compared to standard-of-care therapies.
Despite clinical advances in the treatment of RA, some people do not achieve optimal control of their disease or they discontinue treatment due to lack of efficacy or side effects, which can lead to long-term damage and disability. In
"Today is an important milestone for the RA community in
"The phase 3 clinical trial program of Olumiant consistently showed significant improvement in clinical signs and symptoms of RA in a wide range of RA patients with a diverse treatment history," said
Olumiant® (baricitinib) is a once-daily oral JAK 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.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is an autoimmune disease characterized by inflammation and progressive destruction of joints. More than 23 million people worldwide suffer from RA.iii Approximately three times as many women as men have the disease.ii Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs (NSAIDs), oral conventional disease-modifying antirheumatic drugs (cDMARDs) - such as methotrexate, the current standard of care, and injectable and intravenous biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.iv Despite current treatment options, many patients do not reach their therapeutic goals or are not able to achieve sustained remission.v There remains an important need to provide additional treatment options to improve overall patient care.
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for patients with rheumatoid arthritis, and reflects Lilly's and
i Report from
iii WHO Global Burden of Disease Report, (table 7, page 32) 2004, http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed: May, 16, 2017)
v McWilliams DF, Kiely PDW, Young A, Walsh DA. Baseline factors predicting change from the initial DMARD treatment during the first 2 years of rheumatoid arthritis: experience in the ERAN inception cohort. BMC Musculoskeletal Disorders. 2013;14:1-7.
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