MHLW (Japan) approves Tavalisse to treat chronic idiopathic thrombocytopenic purpura.- Kissei
Kissei Pharmaceutical Co., Ltd. announced that the Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval to Kissei for the oral spleen tyrosine kinase (SYK) inhibitor, Tavalisse Tab. 100mg and 150mg (generic name: fostamatinib disodium hexahydrate, development code: R788), for chronic idiopathic thrombocytopenic purpura (chronic ITP).
Tavalisse is an oral SYK inhibitor discovered by Rigel Pharmaceuticals, Inc.. It suppresses platelet destruction by macrophages thereby preventing platelet depletion and potentially improving the bleeding symptoms caused by chronic ITP. Tavalisse' has a different mechanism of action than existing treatments. Therefore, it represents a new treatment option for patients with chronic ITP who have had an insufficient response to or were unable to tolerate conventional treatments such as steroids.
The approval is based on the the results of the Phase III clinical trials of Tavalisse in ITP patients in Japan and outside of Japan. The results of the Japanese Phase III clinical trial (Study R788-1301) were published in the British Journal of Haematology in December 2022 (https://doi.org/10.1111/bjh.18582 18582).
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