In March 30 2012 Kyowa Hakko Kirin reported that it has received approval for a new drug application (NDA) from the Ministry of Health, Labour and Welfare (MHLW) for POTELIGEO (Mogamulizumab) Injection ("POTELIGEO") that is a therapeutic antibody for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL) (Press release Kyowa Hakko Kirin, MAR 30, 2012, View Source [SID:1234500290]).
POTELIGEO is a humanized monoclonal antibody produced by applying POTELLIGENT, a technology to produce antibodies with enhanced ADCC activity, which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has an NDA approved, and is also the world’s first POTELLIGENT antibody approved for marketing approval. POTELIGEO binds to CCR4 that is expressed on the surface of ATL cells. POTELIGEO was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the MHLW.
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