Zenyaku Kogyo, Chugai Pharma announce Japanese approval for Rituxan for suppression and treatment of antibody-mediated rejection in organ transplantation

Zenyaku Kogyo Co., Ltd. and Chugai Pharmaceutical Co., Ltd. announced that Zenyaku obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), for an anti-CD20 monoclonal antibody Rituxan intravenous injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for “suppression and treatment of antibody-mediated rejection in organ transplantation.”

Antibody-mediated rejection after organ transplantation is a major cause of malfunction or extinction of the transplanted organ. Therefore, if the production of causative antibodies is suppressed or removed before transplantation, and the antigen-antibody reaction at the time of transplantation is suppressed (desensitization), transplantation will be possible even for blood type incompatible transplantation, which have a high risk of antibody-mediated rejection, and for cases in which the recipient has antibodies specific to human leukocyte antigen (HLA). If a rejection reaction occurs, treatment by suppressing the antigen-antibody reaction is expected to maintain or restore transplanted organ function.

Rituxan is an anti-CD20 monoclonal antibody that specifically binds to CD20, a protein expressed on B cells, excluding hematopoietic stem cells and plasma cells. It attacks target B cells using the immune system equipped with the human body, and damages cells. This mechanism of action suppresses the differentiation of B cells into antibody-producing cells, and is expected to suppress antibody production for transplanted organs.

The development of Rituxan for “suppression and treatment of antibody-mediated rejection in organ transplantation” had started based on the results of the “34th Meeting on Unapproved and Off-label Drugs with High Medical Needs (held on March 23, 2018).”

The study was triggered by the 3rd call for requests for unapproved and off-label drugs with high medical needs that began from August 2013. At that time, the Japan Society of Transplantation submitted development requests for “treatment of antibody-mediated rejection in kidney transplantation” and “preoperative desensitization in anti-donor antibody-positive kidney transplantation.”

Based on the results of usage survey conducted by the Japan Society of Transplantation, clinical trials were conducted for suppression of antibody-mediated rejection in kidney transplantation and treatment of antibody-mediated rejection. In addition, in a specific clinical study conducted by the transplant medical technology development research project of the Japan Agency for Medical Research and Development, suppression and treatment of antibody-mediated rejection for liver, heart, lung, pancreas and small intestine transplantation were investigated. Based on the data obtained from these studies, Zenyaku submitted an application for partial changes to the manufacturing and sales approval items on April 6, 2023, which led to the current approval.

Zenyaku and Chugai will continue working closely together so that Rituxan may contribute to the suppression and treatment of antibody-mediated rejection in organ transplantation.

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