Mitsubishi Tanabe Pharma Corporation announced that it has received approval for an additional indication for Remicad for I.V. Infusion 100 (generic name: infliximab), an anti-human TNFα monoclonal antibody. The additional indication is for acute-stage Kawasaki disease for which existing treatments are not sufficiently effective.
Acute-stage Kawasaki disease can result in the development of coronary lesions (coronary artery expansion or aneurysm formation). Consequently, a therapeutic goal is to rapidly address acute-stage symptoms, such as fever. However, there are patients for which existing treatments are not sufficiently effective and additional treatment is needed, and there are reports that one in four of these patients has coronary lesions. Accordingly, the development of new treatment agents has been needed.
In response to these strong medical needs, Mitsubishi Tanabe Pharma implemented domestic clinical trials for patients with Kawasaki disease for which existing treatments are not sufficiently effective. As a result, the efficacy and safety of Remicade were confirmed, and following accelerated examination by the Ministry of Health, Labour and Welfare, the Company was able to rapidly obtain approval for this indication.
