Approval for Additional Indication of Psoriasis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF-α Monoclonal-Antibody
2010-01-20 · Tanabe Pharma Corporation · original tanabe-pharma.com ↗
January 20, 2010 Mitsubishi Tanabe Pharma Corporation Approval for Additional Indication of Psoriasis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF-α Monoclonal Antibody Osaka, Japan, January 20, 2010 ---- Mitsubishi Tanabe Pharma Corporation (President & CEO, Michihiro Tsuchiya) announced today that the Company received, as of January 20, 2010, approval for the additional indication of psoriasis (plaque psoriasis, psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis) for Remicade® I.V. Drip Infusion 100 (generic name: infliximab), anti-human TNF-α monoclonal antibody. Psoriasis is an intractable chronic skin disease with such symptoms as swelling skin rashes, and dried, silvery scales exfoliating from the skin. Ninety percent of psoriasis patients are classified into this type of plaque psoriasis, which may affect the entire body in some patients, while lesions may appear on a small area of the body in other patients. Other types of psoriasis include psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis. Psoriatic arthritis is a form of chronic arthritis with progression of joint destruction in similar ways as rheumatoid arthritis, as well as skin symptoms that resemble plaque psoriasis symptoms. In pustular psoriasis, pus-filled blisters appear on the skin, and erythrodermic psoriasis may affect the entire body with red inflammatory skin symptoms. In particular, generalized pustular psoriasis is designated as an intractable disease by the government. Psoriasis is a disease well-known for deteriorating the patients' quality of life by significant levels, the reason being severe emotional distress, and the difficulty in making complete recovery. In clinical studies for the use of Remicade on psoriasis patients who did not respond to conventional therapies, the lesions were evaluated by using the PASI score. Remicade has shown its significant efficacy by improving symptoms on over 80% of patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and erythrodermatic psoriasis, and the efficacy had never been obtained with other existing treatments. Remicade has been used to treat more than 50,000 patients in Japan with Crohn's disease, rheumatoid arthritis, and refractory uveoretitis in Behcet's disease, and has accumulated enough evidence on its efficacy and safety as a biological substance. Mitsubishi Tanabe Pharma will contribute to the improvement of the quality of life in patients suffering from psoriasis, through encouraging the proper use of Remicade, and conducting Post-Marketing Surveillance with every patient. With this, we will provide reliable safety information to patients and healthcare professionals, as we have successfully completed in Crohn’s disease, rheumatoid arthritis and Behcet’s disease. 〈〈For Details, Contact the Following Section〉〉 Corporate Communications Dept., Mitsubishi Tanabe Pharma Corporation Tel +81-6-6205-5211
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