Kyowa Hakko Kirin Receives the Partial Change Approval of Romiplate® for Aplastic Anemia in Japan
June 18, 2019
Tokyo, Japan, June 18, 2019 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") announced today that it has received the partial change approval of Romiplate® (code name: AMG531, generic name: romiplostim (recombinant), "the drug") for an additional indication of treatment of aplastic anemia (AA) in patients who have had an inadequate response to conventional therapy from Japan's Ministry of Health, Labour and Welfare (MHLW).
The drug is composed of recombinant protein stimulating hematopoiesis via acting on the thrombopoietin receptors. It was launched for the treatment of idiopathic thrombocytopenic purpura (ITP) and has contributed to many ITP patients since April 2011.
"Aplastic Anemia is still a disease with high unmet medical needs," said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin. "I'm pleased that from today another option is available for AA patients who are refractory to or ineligible for immunosuppressive therapy"
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
- About Aplastic Anemia
- Aplastic anemia is a disease with deficiency of all blood cell type (pancytopenia) and decreases population of stem cells (hypoplasia).
- About Thrombopoietin
- Thrombopoietin (TPO) is a main hematopoietic growth factor that stimulates hematopoiesis and platelet production.
- About Idiopathic Thrombocytopenic Purpura
- Idiopathic thrombocytopenic purpura is an autoimmune disease in which the person has reduced platelets caused by the production of autoantibody against individual's platelet.
