{"id":3280,"date":"2018-11-26T09:47:51","date_gmt":"2018-11-26T09:47:51","guid":{"rendered":"https:\/\/sprengthomson.com\/?p=3280"},"modified":"2024-04-12T11:08:17","modified_gmt":"2024-04-12T11:08:17","slug":"kyowa-kirin-announces-poteligeo-receives-marketing-authorisation-in-europe-for-the-treatment-of-mycosis-fungoides-and-sezary-syndrome","status":"publish","type":"post","link":"https:\/\/sprengthomson.com\/kyowa-kirin-announces-poteligeo-receives-marketing-authorisation-in-europe-for-the-treatment-of-mycosis-fungoides-and-sezary-syndrome\/","title":{"rendered":"Kyowa Kirin Announces POTELIGEO\u00ae Receives Marketing Authorisation in Europe for the Treatment of Mycosis Fungoides and S\u00e9zary Syndrome"},"content":{"rendered":"
POTELIGEO will be the first biologic agent targeting CCR4 <\/em>to be available for patients in Europe.<\/em><\/p>\n Tokyo, Japan, 26th<\/sup> November, 2018<\/strong> \u2013 <\/strong>Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that it has received a European Commission decision granting a marketing authorisation to POTELIGEO\u00ae<\/sup><\/strong> (Generic name: mogamulizumab), a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or S\u00e9zary syndrome (SS) who have received at least one prior systemic therapy.<\/p>\n MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin\u2019s lymphoma.<\/p>\n The European Medicines Agency (EMA)\u2019s Committee for Medicinal Products for Human Use (CHMP), adopted a Positive Opinion recommending approval of the marketing authorisation for POTELIGEO in September 2018.<\/p>\n The European Marketing Authorisation is valid in the 28 countries of the European Union and in Norway, Iceland and Liechtenstein. Kyowa Kirin plans to launch POTELIGEO in various markets in Europe from 2019. Kyowa Kirin International PLC, a Kyowa Hakko Kirin Group company, is responsible for commercialising POTELIGEO in Europe.<\/p>\n \u201cWith this approval, now there is a new option for the patients with mycosis fungoides (MF) or S\u00e9zary syndrome (SS) across Europe,\u201d said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Kirin. \u201cI\u2019m delighted about the European Commission\u2019s decision which is strategically important for us to realise our mid-term business plan and our goal as a global specialty pharmaceutical company.\u201d<\/p>\n Tom Stratford, CEO of Kyowa Kirin International, said: \u201cMycosis fungoides (MF) and S\u00e9zary syndrome (SS) are horrible conditions which patients literally wear on their skin. The granting of this marketing authorisation is encouraging news for those across Europe who live with these conditions every day and we look forward to making POTELIGEO available for patients and clinicians across Europe.\u201d<\/p>\n \u201cPOTELIGEO offers a new approach to tackling the underlying disease pathophysiology of mycosis fungoides (MF) and S\u00e9zary syndrome (SS). By targeting CCR4-expressing T cells in blood and skin we could have a new option to manage patient symptoms.\u201d Said Professor Martine Bagot, Head of the Department Dermatology in Hospital Saint Louis, Paris.<\/p>\n 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.<\/p>\n