Tokyo, Sept 11, 2012 - (JCN Newswire) - Eisai Co., Ltd. announced today that it will launch the anti-rheumatic agent Careram(R) (iguratimod) in Japan on September 12 for the treatment of rheumatoid arthritis. Careram, jointly developed in Japan by Eisai and Toyama Chemical Co., Ltd. from the Phase III clinical development stage, was approved by Japan's Ministry of Health, Labour and Welfare (MHLW) in June of this year and was subsequently listed on the National Health Insurance Drug Price List on August 28.
Careram is a novel disease-modifying anti-rheumatic drug (DMARD) that exhibits anti-rheumatic effects by primarily suppressing the production of immunoglobin and inflammatory cytokines. In a Phase III clinical study of Careram administered as a monotherapy in patients with rheumatoid arthritis, Careram demonstrated superiority over placebo as well as non-inferiority compared to an existing DMARD(salazosulfapyridine). It is also the only oral anti-rheumatic agent currently approved in Japan to demonstrate efficacy in domestic clinical trials as an add-on therapy to methotrexate ("MTX"), the standard of care, in rheumatoid arthritis patients who did not achieve satisfactory benefit with MTX alone.
In a trial of Careram in combination with MTX(1) conducted in this patient population, patients who were administered a combination of the two agents demonstrated favorable tolerability as well as significant improvements compared to those treated with placebo (MTX-only arm) in the study's primary endpoint of ACR20 response rate at Week 24.
In Japan, rheumatoid arthritis is said to affect an estimated 700,000 to 800,000 patients. Eisai, which currently markets the rheumatoid arthritis treatment Humira(R)(2) and the analgesic/anti-inflammatory agent Infree(R), has extensive data and experience in the field of rheumatoid arthritis. By providing Careram as a new option for the pharmacological treatment of rheumatoid arthritis, Eisai believes that it can make further contributions to address the diversified needs of rheumatoid arthritis patients and increase their quality of life. Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered Careram until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW. After confirming the safety of Careram through the all case surveillance, Eisai will strive to provide information on proper use of the agent in hope that more patients will use it.
For product details and more about the Careram-MTX Combination Trial, please visit http://www.eisai.com/news/enews201261pdf.pdf.
1) Please refer to "About the Careram-MTX Combination Trial"2) Co-promoted with Abbott Japan Co., Ltd. under a one brand, one channel, two promotion scheme.
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
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