Lilly and Incyte Provide Update on Baricitinib
"We disagree with the
The
The NDA for RA contained the results of four positive Phase 3 clinical trials that met their primary endpoints and in which 3,100 patients were enrolled, across the full spectrum of RA patients from treatment-naïve to highly-treatment refractory. Thromboembolic events - diagnosed as deep venous thrombosis (DVT) and pulmonary embolism (PE) - were reported in five patients receiving baricitinib during the controlled period of two of seven completed Phase 2 or Phase 3 trials in RA. Although an imbalance was observed during the placebo controlled period of the RA clinical trials, the rate of these events in the overall baricitinib clinical program was consistent with that seen among the general population of treated RA patients.
In the
About Baricitinib
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.
In
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
Lilly and
About Incyte
Incyte Corporation is a Wilmington,
Follow @Incyte on Twitter at https://twitter.com/Incyte.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
P-LLY
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
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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
iiiWHO 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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