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EU approves Kyowa Kirin’s drug for rare lymphoma

November 30, 2018 By pharmaphorum

The drug is manufactured by Japanese firm Kyowa Hakko Kirin (Kyowa Kirin), and is for adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Poteligeo is a humanised monoclonal antibody, which acts against the against CC chemokine receptor 4 (CCR4), which is often found in the cells of patients with certain haematologic malignancies including CTCL (cutaneous T-cell lymphoma).

The treatment is the first biologic available to patients in Europe who have MF or SS. Approval was based on the results of a phase 3 trial in which Poteligeo demonstrated a median progression-free survival (PFS) of 7.7 months compared with 3.1 months for those prescribed histone deacetylase (HDAC) inhibitor vorinostat.

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

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), gave Poteligeo a positive opinion recommending approval of the marketing authorisation in September. Such recommendations are usually followed by market approval.

Mitsuo Satoh, vice president head of R&D division of Kyowa Kirin, added: “With this approval, now there is a new option for the patients with mycosis fungoides or Sézary syndrome across Europe.

“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.”

Kyowa Kirin plans to launch the therapy in various markets in Europe from 2019.

The US Food and Drug Administration approved Poteligeo in August this year for the treatment of relapsed or refractory MF and SS.

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