2021/12/24
Keio University Hospital
Keio University School of Medicine
Zenyaku Kogyo Co., Ltd., the marketing authorization holder for rituximab (product name: Rituxan® for intravenous infusion 100 mg/500 mg, hereinafter "Rituxan"), has received regulatory approval from the Ministry of Health, Labour and Welfare for an additional indication for pemphigus. This approval is based on an investigator-initiated, multicenter, collaborative clinical trial titled "An investigator-initiated, open-label, single-arm, multicenter, collaborative phase II clinical trial of rituximab for patients with steroid-refractory pemphigus." The trial was led by a group from the Department of Dermatology, Keio University School of Medicine, including Professor Masayuki Amagai and Dr. Jun Yamagami (then a senior lecturer, currently an associate professor at Tokyo Women's Medical University).
Pemphigus is an autoimmune disease designated as an intractable disease by the Japanese government. It is caused by autoantibodies against molecules crucial for intercellular adhesion (desmoglein 1 and 3), leading to blisters and erosions on the skin and mucous membranes. Treating refractory cases that do not respond to conventional treatments centered on steroids has been a long-standing challenge. The aforementioned clinical trial, which provided a key basis for this regulatory approval, was conducted with support from the Japan Agency for Medical Research and Development (AMED) (Practical Research Project for Rare/Intractable Diseases) and Zenyaku Kogyo Co., Ltd. The trial was led by Keio University Hospital as the central site, in collaboration with three other institutions nationwide: Hokkaido University Hospital, Okayama University Hospital, and Kurume University Hospital. This regulatory approval is expected to significantly expand treatment options for refractory pemphigus and improve remission induction rates.
Please see below for the full press release.