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Mogamulizumab receives positive opinion for mycosis fungoides and Sézary syndrome

Kyowa Kirin has announced that it has received a European Commission decision granting a marketing authorisation to Poteligeo® (mogamulizumab), a humanised monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

MF and SS are the two most common subtypes of cutaneous T-cell lymphoma (CTCL), a rare type of non-Hodgkin’s lymphoma.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), adopted a Positive Opinion recommending approval of the marketing authorisation for Poteligeo in September 2018.

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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.

With this approval, now there is a new option for the patients with mycosis fungoides (MF) or Sézary syndrome (SS) across Europe,” said Mitsuo Satoh, PhD, Executive Officer, Vice President Head of R&D Division of Kyowa Kirin. “I’m delighted about the European Commission’s decision which is strategically important for us to realise our mid-term business plan and our goal as a global specialty pharmaceutical company.”

Tom Stratford, CEO of Kyowa Kirin International, said: “Mycosis fungoides (MF) and Sézary 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.”

Poteligeo offers a new approach to tackling the underlying disease pathophysiology of mycosis fungoides (MF) and Sézary syndrome (SS). By targeting CCR4-expressing T cells in blood and skin we could have a new option to manage patient symptoms”, said Professor Martine Bagot, Head of the Department Dermatology in Hospital Saint Louis, Paris.