Abbott Japan and Eisai have Cleared the Condition for Approval of Humira(R), a Fully Human Anti-TNF-Alpha Monoclonal Antibody, for Plaque Psoriasis and Psoriasis Arthropica in Terms of the All-Case Surveillance
Tokyo, Apr 23, 2012 – (JCN Newswire) – Abbott Japan Co., Ltd. and Eisai Co., Ltd. announced today that they have received notification from Japan’s Ministry of Health, Labour and Welfare (MHLW) that the condition for approval of Humira(R) pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (adalimumab [genetical recombination]), a fully human anti-TNF-alpha monoclonal antibody, has been lifted in terms of a drug use results survey (all-case surveillance) for plaque psoriasis and psoriasis arthropica.
In approving plaque psoriasis and psoriasis arthropica as additional indications for Humira in January 2010, the MHLW imposed the following condition: “A post-marketing drug use results survey of all patients receiving Humira must be conducted until data has been collected for a pre-determined number of cases in order to promptly obtain safety and efficacy data for the drug, and appropriate measures must be taken to ensure its proper use.”
The MHLW lifted the condition for approval based on a review of safety and efficacy data for Humira submitted to the Ministry in an interim report outlining analysis results of the all-case surveillance of 634 patients with plaque psoriasis and psoriasis arthropica.
Based on evidence obtained through the survey, Abbott Japan and Eisai will continue to ensure, and provide information on, the proper use of Humira as they seek to make further contributions to improve the quality of life of patients.
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.co.jp/index-e.html
Public Relations Department Eisai Co., Ltd. Tel: +81-3-3817-5120 Public Affairs Department Abbott Japan Co., Ltd. Tel: +81-3-4588-4602 >
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