European Commission Approves Once-Daily Olumiant Tablets for Treatment of Adults with Moderate-to-Severe Active Rheumatoid Arthritis
Baricitinib, marketed as Olumiant, is the first JAK inhibitor approved to treat RA in the EU
This is the first regulatory approval around the world for Olumiant -- the first JAK inhibitor approved to treat RA in the
"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
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.
As a result of the approval of Olumiant by the
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.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA 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 RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.
About Baricitinib Phase 3 Trials
Incyte Corporation is a Wilmington,
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About Eli Lilly and Company
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*The brand listed is a trademark of AbbVie and is not a trademark of
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 treatment for patients with rheumatoid arthritis and reflects Lilly's and
i American College of Rheumatology, Rheumatoid Arthritis, http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp. Accessed
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf. Accessed
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
iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php. Accessed
v Rheumatoid arthritis,
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice,
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