Publicado 08/08/2018 18:41
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Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary

Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world. Kyowa Kirin International PLC is a wholly owned subsidiary of Kyowa Hakko Kirin and is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in Europe and the United States. Kyowa Kirin International is headquartered in Scotland. You can learn more about the business at: http://www.kyowa-kirin.com.

About POTELIGEO 

POTELIGEO is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL (cutaneous T-cell lymphoma). POTELIGEO was produced using Kyowa Hakko Kirin's proprietary POTELLIGENT(R) platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC).

In August 2017, the FDA granted POTELIGEO Breakthrough Therapy Designation status for the treatment of MF and SS in adult patients who have received at least one prior systemic therapy. In November 2017, the FDA accepted the BLA for filing and granted POTELIGEO Priority Review. POTELIGEO received FDA approval in August 2018.

About mycosis fungoides (MF) and Sézary syndrome (SS) 

MF and SS are the two most common subtypes of CTCL, a rare type of non-Hodgkin's lymphoma, which is characterized by localization of malignant T lymphocytes to the skin, and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera.

CONTACT: Contact Kyowa Hakko Kirin Co. Ltd., Media, Hiroki Nakamura,+81-3-5205-7205, Email: media@kyowa-kirin.co.jp, Callum Spreng, SprengThomson Ltd. (For Kyowa Kirin International PLC), +44 (0)141 548 5191,Mobile: +44 (0)7803 970103, Email: Callum@sprengthomson.com, YvetteVenable, Kyowa Kirin International PLC, +1 908-375-2358, Or +44 7388 222769, Email: Yvette.Venable@kyowakirin.com

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