Kyowa Kirin
Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd., and Swixx BioPharma AG has announced that the Polish Ministry of Health has approved the reimbursement of POTELIGEO (mogamulizumab) in second-line monotherapy for adult patients with Stage IB and above mycosis fungoides (MF), and Sézary syndrome (SS).
MF and SS are two subtypes of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin and can have debilitating physical, emotional and social challenges. MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs. With an average time to diagnosis of 3-4 years, MF is typically characterised by skin symptoms including patches or plaques, skin redness and tumours. SS is much rarer, accounting for around 5% of CTCLs, and is more aggressive, causing severe itching, erythroderma, intense scaling of the skin and frequent hair loss.
Jeremy Morgan, President of Kyowa Kirin International said: “I am delighted that the Ministry of Health has agreed to reimburse POTELIGEO for MF and SS patients in Poland. Our purpose at Kyowa Kirin is to make people smile, and I am proud to see us living this purpose and achieving such an important milestone for the CTCL community. With a commitment to delivering life changing value for people impacted by under-diagnosed and under-served diseases, approval in Poland now means mogamulizumab is reimbursed in almost 30 countries across the EMEA region, and is a critical step in helping to meet the needs of people living with CTCL.”
Kyowa Kirin International and Swixx BioPharma AG signed a Promotion and Distribution Agreement in October 2022. Under the terms of the agreement, Swixx exclusively markets, promotes and distributes mogamulizumab in Poland.
Michał Opuchlik, General Manager of Swixx BioPharma Poland, commented: “The positive reimbursement decision of the Polish Ministry of Health is surely an important achievement for patients in Poland suffering from CTCL. We are very proud that, thanks to the great cooperation between Swixx BioPharma, Kyowa Kirin and all our stakeholders in Poland, we were able to ensure that patients now have access to this medicine, that received the FDA's breakthrough therapy designation several years ago. At Swixx BioPharma we are proud of our mission to bring the innovative therapies of our partners to patients in need and this milestone once again positions Swixx BioPharma Poland among the leading companies securing access to innovative treatments in our country.”