Anti-CD20 MAb Rituxan approved for ITP in Japan

Japanese drugmaker Chugai (TYO: 4519), which is majority owned by Roche (ROG: SIX), On Friday revealed that Zenyaku Kogyo has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), for an additional dosage and administration of an anti-CD20 monoclonal antibody Rituxan (rituximab) intravenous injection 100mg and 500mg, which is co-marketed by both companies, for chronic idiopathic thrombocytopenic purpura (ITP)  in children.

Chronic ITP had previously only been approved for use in adults with specified dosage and administration, and its use in children had not been approved. The Japanese Society of Pediatric Hematology/Oncology requested the addition of dosage and administration for Rituxan for “chronic ITP in children.”

It was evaluated because this request qualified for a public knowledge-based application at the “58th evaluation committee on unapproved or off-labeled drugs with high medical needs” held on March 22, 2024. It was officially decided that a public knowledge-based application could be submitted at the Pharmaceutical Affairs Council’s First Committee on Drugs held on April 26, 2024. In response to this, Zenyaku submitted a public knowledge-based application for the addition of dosage and administration on May 24, 2024, and obtained approval.