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Toyama Chemical and Eisai clear all-case surveillance condition for approval of antirheumatic agent Igratimod (brand names:KOLBET® tablets 25mg/Careram® tablets 25mg)
|December 1, 2015|
Fujifilm Group company Toyama Chemical Co., Ltd. (Headquarters: Tokyo, President: Masuji Sugata, “Toyama Chemical”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that they have received notification from Japan’s Ministry of Health, Labour and Welfare (MHLW) to the effect that the “all-case surveillance” special drug use-results survey condition required for approval of the antirheumatic agent iguratimod (Toyama Chemical brand name: KOLBET®, Eisai brand name: Careram®) has been lifted.
In June 2012, the MHLW approved iguratimod indicated for rheumatoid arthritis with the following condition for approval: “After the launch of iguratimod, the use-results survey should be conducted for all patients treated with this product until adequate data from a certain number of cases have been collected, in order to understand the background of those patients, and efficacy and safety data on this product be collected just after marketing of the product so that actions necessary for the proper use of the drug can be taken.” Toyama Chemical and Eisai jointly conducted an all-case drug use-results survey on all patients who had been treated with iguratimod between launch on September 12, 2012 to April 14, 2013, and submitted the results of an interim analysis on the first 24 weeks of treatment for 2,246 patients to the MHLW. Based on the safety and efficacy data submitted, the MHLW lifted this condition for approval after determining that there are no issues that require new measures to ensure proper use of the product.
Discovered by Toyama Chemical, iguratimod is a disease-modifying antirheumatic drug (DMARD) and was the first oral antirheumatic agent 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. As an antirheumatic drug, it is believed that iguratimod provides a new option for drug therapy of rheumatoid arthritis and enables rheumatoid arthritis patients to choose a drug therapy regime that matches their condition. Toyama Chemical and Eisai conducted joint development of the agent in Japan based on a co-development and license agreement previously concluded between the two companies. After receiving approval, Taisho Toyama Pharmaceutical Co., Ltd. and Eisai launched iguratimod under the brand names KOLBET® Tablets 25 mg and Careram® Tablets 25 mg, respectively, with each company working to market their product and provide information on its proper use.
Toyama Chemical and Eisai will continue to promote and provide information on the proper use of iguratimod while making further contributions to improve the quality of life of patients.
≪Notes to editors≫
1. Results of the All-Case Surveillance
2. About Rheumatoid Arthritis
3. About Disease-Modifying Antirheumatic Drugs (DMARDs)
4. About DAS28-ESR and DAS28-CRP