Kyowa Kirin and Swixx BioPharma Expand Access to POTELIGEO® for Mycosis Fungoides and Sézary Syndrome in Central and Eastern Europe
Kyowa Kirin International (KKI), a fully owned subsidiary of Kyowa Kirin Co. Ltd., in partnership with Swixx BioPharma AG, recently announced that both the Croatian National Health Insurance Fund (NHIF) and the Bulgarian Ministry of Health have approved the reimbursement of POTELIGEO® (mogamulizumab) for adult patients diagnosed with mycosis fungoides (MF) and Sézary syndrome (SS), two rare and challenging subtypes of cutaneous T-cell lymphoma (CTCL). This significant development expands patient access to an innovative treatment that addresses critical unmet medical needs in these countries.
The Impact of Mycosis Fungoides and Sézary Syndrome
Mycosis fungoides and Sézary syndrome are both forms of cutaneous T-cell lymphoma (CTCL), a rare and complex type of non-Hodgkin’s lymphoma that primarily affects the skin. CTCL can be debilitating, leading to both physical and emotional challenges for patients, including severe itching, skin lesions, and the risk of spreading to other organs. MF, the more common subtype of CTCL, accounts for about 60% of all CTCL cases and typically manifests through skin changes such as red patches, plaques, or tumours, along with a long diagnostic delay. On average, the time from initial symptom presentation to diagnosis of MF can range from 3 to 4 years. SS, by contrast, is much rarer, representing only 5% of CTCL cases, and is more aggressive. SS presents with symptoms such as severe itching, erythroderma (redness and scaling of the skin), and widespread hair loss, often resulting in a more rapid decline in the patient’s health.
Both conditions present significant challenges, not only due to their rarity but also because of the complexity of diagnosing and treating them. Early recognition and access to appropriate therapies are critical for managing these diseases effectively. Yet, for many patients, particularly in Central and Eastern Europe, treatment options have been limited.
Reimbursement Approvals in Croatia and Bulgaria
The recent decisions by the Croatian NHIF and the Bulgarian Ministry of Health to reimburse POTELIGEO® mark a major milestone in the ongoing effort to provide better care options for people living with these rare diseases in the region.
The approval in Croatia became effective on November 15, 2024, and in Bulgaria, reimbursement was confirmed on January 2, 2025. These decisions follow the inclusion of POTELIGEO® in the Polish Ministry of Health’s Drug Programme, announced in July 2024, and they further reinforce the growing availability of this important therapy in the region. This expansion of access demonstrates Kyowa Kirin’s commitment to improving the lives of patients with CTCL in underserved areas.
Jeremy Morgan’s Remarks on Reimbursement Approvals
Jeremy Morgan, President of Kyowa Kirin International, expressed his enthusiasm about these developments: “I am delighted that the Croatian and Bulgarian authorities have agreed to reimburse POTELIGEO for MF and SS patients. Both decisions are significant milestones for those affected by these rare and difficult-to-treat forms of CTCL. With mogamulizumab now reimbursed in over 20 countries across the EMEA region, we remain as committed as ever to delivering life-changing value for people affected by under-diagnosed and under-served diseases. Our mission is to bring smiles to more faces by ensuring broader access to this essential treatment.”
Swixx BioPharma’s Role in Expanding Access
Swixx BioPharma has played a key role in the distribution and promotion of POTELIGEO® in Central and Eastern Europe. The company has been tasked with the exclusive marketing, promotion, and distribution of mogamulizumab in Croatia and Bulgaria, as part of a broader agreement made with Kyowa Kirin in October 2022. The partnership also includes other countries in the region, and Swixx BioPharma is working to expand access to the treatment for patients facing the challenges of MF and SS.
Dezso Martha, Chief Operating Officer of Swixx, emphasized the company’s commitment to improving patient access to innovative therapies. “At Swixx, our mission is to unlock access to innovative medicines. The recent reimbursement approvals in Croatia and Bulgaria are significant steps forward in improving therapeutic options for patients with MF and SS in these markets,” Martha stated. “We are dedicated to working closely with health authorities, the scientific community, and Kyowa Kirin to expand access to this critical medicine, ensuring better outcomes for patients across the Central and Eastern European region.”
POTELIGEO®: An Innovative Therapy for CTCL
Poteligeo® (mogamulizumab) is an innovative monoclonal antibody treatment that has shown significant efficacy in treating adult patients with MF and SS, two of the most challenging subtypes of CTCL. It works by targeting a protein called CCR4, which is expressed on the surface of malignant T-cells, effectively interfering with the progression of the disease. By selectively targeting these T-cells, mogamulizumab helps reduce the skin lesions, symptoms, and overall disease burden for patients.
This therapy is a much-needed option for patients with MF and SS who have not responded to other treatments or have experienced limited benefits from standard care. With its approval for reimbursement in multiple countries, including Croatia, Bulgaria, and Poland, POTELIGEO® provides a crucial new avenue of treatment for those affected by these rare and debilitating conditions.
Expansion Across Central and Eastern Europe
The approval of reimbursement for POTELIGEO® in Croatia and Bulgaria is part of a broader effort to expand access to this life-changing therapy across Central and Eastern Europe. Kyowa Kirin and Swixx BioPharma are committed to improving patient outcomes by working closely with health authorities, healthcare Kyowa providers, and the scientific community to increase awareness, facilitate diagnoses, and ensure that patients have access to the most effective treatment options available.
As of now, mogamulizumab is available in over 20 countries across the EMEA region, and efforts are underway to expand its availability even further. The partnership between Kyowa Kirin and Swixx BioPharma is critical to this expansion, and both companies remain dedicated to advancing the treatment landscape for patients with CTCL.
