drugset / Press release

Remicade® for I.V. Infusion 100, Anti-Human TNF α Monoclonal Antibody A New Option to Shorten Infusion Time

2012-05-08 · Tanabe Pharma Corporation · original tanabe-pharma.com ↗

May 8, 2012 Mitsubishi Tanabe Pharma Corporation Remicade® for I.V. Infusion 100, Anti-Human TNF α Monoclonal Antibody A New Option to Shorten Infusion Time Osaka, Japan, May 8, 2012--- Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that a label extension for the anti-human TNF α monoclonal antibody, Remicade ® for I.V. Infusion 100 (generic name: infliximab) allows a shortened infusion time in carefully selected patients treated with Remicade ®, from their fourth infusion. This new option of shortening infusion time is expected to offer greater convenience for both patients and clinical settings. Remicade ® has been administered to patients over two hours in the past, however, patients and medical institutions across Japan have requested shorter infusion time. These lead to the studying of the situation in Europe where this has already been approved*, the results of domestic clinical trials and post-marketing surveillance, and other information. As a result, it has been approved to allow a shorter infusion time for patients who have tolerated three initial infusions (at weeks 0, 2, and 6), without exceeding an average of 5 mg/kg per hour. * In Europe, the label extension for Remicade ® to shorten infusion time to one hour was approved for rheumatoid arthritis in 2006 and for all other indications in 2011. May 2012 will mark the 10th anniversary of Remicade ® launch in Japan. During that decade, a total of 80,000 patients of all the indications, including over 50,000 rheumatoid arthritis patients, have been treated with th is drug. Evidence accumulated through the post-marketing surveillance on all patients of each disease now constitutes precious information that is essential for proper use of the drug for Japanese patients. Mitsubishi Tanabe Pharma Corporation will continue providing drug information prioritizing its safe and proper use, and through Remicade®, the Company will strive to meet the expectations of patients and healthcare professionals. <Media enquiry> Corporate Communications Department Phone: +81 6-6205-5211

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