National Health Service

LEO Pharma has announced that its Anzupgo (delgocitinib) cream has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat chronic hand eczema (CHE). The treatment has been specifically authorised for use in adults with moderate-to-severe cases of the inflammatory skin disease for whom topical corticosteroids are inadequate or inappropriate. CHE is defined as hand eczema that lasts for more than three months or relapses at least twice within a year. Alongside physical symptoms such as itch and pain, the condition has been shown to cause psychological and functional burdens that impact quality of life, with approximately 70% of patients with severe cases reporting problems performing everyday activities. LEO’s Anzupgo is designed to inhibit the activation of the JAK-STAT signalling pathway, which plays a key role in CHE, and is now the first topical pan-JAK inhibitor treatment approved by the MHRA specifically for adults with moderate-to-severe CHE. The UK regulator’s decision, which comes less than three months after the European Commission approved Anzupgo for the same indication, was supported by positive results from the phase 3 DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream. The primary endpoint, Investigator’s Global Assessment for CHE treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16. Data from the 36-week DELTA 3 open-label extension trial also informed the approval. Leanne Walsh, vice president and general manager, LEO Pharma UK and Ireland, said the approval “marks a significant milestone for adults in Great Britain living with moderate-to-severe CHE”. Also commenting on the authorisation, Richard Warren, consultant dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester, said: “The physical symptoms of CHE can be debilitating, substantially disrupting patients’ lives… [The] approval of a first, topical JAK inhibitor treatment option for moderate-to-severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” LEO said it is now “collaborating closely” with the National Institute for Health and Care Excellence to make Anzupgo cream available on the NHS.

MAIDENHEAD, England--( BUSINESS WIRE )--NOT FOR UK USE - NOT INTENDED FOR UK MEDIA LEO Pharma, a global leader in medical dermatology, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for delgocitinib cream for the treatment of adult patients with moderate to severe Chronic Hand Eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 1 CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain across the hands and wrists. 2,3 Its pathophysiology is characterised by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. 2 Hand Eczema is categorised as CHE when it lasts for more than three months, or relapses twice or more often per year. 3,4 The condition can have a high psychological, social, and occupational burden. 5,6 “ The physical symptoms of Chronic Hand Eczema can be debilitating, substantially disrupting patients' lives. Additionally, patients report that the disease can profoundly affect their mental well-being, relationships, and daily activities,” shared Prof. Richard Warren, Consultant Dermatologist at Northern Care Alliance NHS Foundation Trust and The University Of Manchester . “ Today’s approval of a first, topical JAK inhibitor treatment option for moderate to severe CHE adult patients adds to the treatment options available for healthcare professionals and patients.” “ Today’s MHRA approval of delgocitinib cream marks a significant milestone for adults in Great Britain living with moderate to severe Chronic Hand Eczema,” said Leanne Walsh, Vice President and General Manager, LEO Pharma UK and Ireland . “ This approval offers a new treatment paradigm and demonstrates our commitment to addressing the unmet needs of people living with skin conditions.” The MHRA decision was based on results from the delgocitinib cream phase 3 program, which included the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to the cream vehicle. 7-9 Both trials met their primary and all secondary endpoints. 9-11 Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial. 12 “ CHE is a truly debilitating condition as patients may live with itchy, sore, scaly, weepy, fissured hands. This can really affect patients' ability to work but also to interact with family and loved ones,” noted Prof. Anthony Bewley, Consultant Dermatologist at Barts Health NHS Trust. “ CHE is so much more than a difficult skin disease, as research has shown that living with CHE can have an impact on patients' psychological well-being, and can lead to anxiety, depression, or both. The development of a new topical treatment for adult patients with moderate to severe CHE is very welcome.” LEO Pharma UK and Ireland is collaborating closely with NICE to make delgocitinib cream available on the NHS. *Ends* Notes to editors About Chronic Hand Eczema Chronic Hand Eczema (CHE) is defined as Hand Eczema (HE) that lasts for more than three months or relapses twice or more within a year. 3,4 CHE is one of the most common skin disorders of the hands 13 with a prevalence rate of approximately 4.7%. 14 In a substantial number of patients, HE can develop into a chronic condition. 13 CHE is a fluctuating disorder characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 5 CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 6 with approximately 70% of individuals who live with severe CHE admitting to problems in performing everyday activities, and suffering disruption in their daily life due to the condition. 15 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 16 About delgocitinib Cream Delgocitinib cream is a topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signalling, which plays a key role in the pathogenesis of CHE. 17 The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome. 2 Delgocitinib cream is currently approved in the European Union and Switzerland for the treatment of moderate to severe CHE in adults for whom topical corticosteroids are inadequate or inappropriate. In 2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a license agreement in which LEO Pharma gained exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where JT retains rights. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,000 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion. References Anzupgo ® (delgocitinib) cream SmPC. LEO Pharma; December 2024 . Lee GR, et al. Dermatol Ther . 2019;e12840:1–12. Lynde C, et al. J Cutan Med Surg. 2010;14:267–284. Erratum in: J Cutan Med Surg. 2011;15:360. Diepgen TL, et al. J Dtsch Dermatol Ges . 2015;13(1):e1–22. Thyssen J, et al. Contact Dermatitis . 2022;86:357–78. Grant L, et al. Adv Ther . 2020;37(2):692-706. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/study/NCT04871711 . Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04872101 . Bissonnette R, et al. Lancet . 2024;404(10451):461-473. Schliemann S, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Bissonnette R, et al. European Academy of Dermatology and Venereology (EADV) Congress . 2023. Clinicaltrials.gov. 2024. Available from: https://clinicaltrials.gov/ct2/show/NCT04949841 . Bissonnette R, et al. JEADV . 2010;24;1–20 Apfelbacher C, et al. European Society of Contact Dermatitis (ESCD) congress . 2024. Cortesi PA, et al. Contact Dermatitis . 2014;70(3):158-168. Voorberg AN, et al. Acta Derm Venereol . 2022;102:adv00626. Dubin C, et al. Ther Clin Risk Manag . 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag . 2021:17:233. MAT-78329 December 2024

The UK’s drug pricing body has affirmed its earlier decision not to recommend coverage of AstraZeneca and Daiichi Sankyo’s breast cancer treatment Enhertu. “As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price,” National Institute for Health and Care Excellence (NICE) Chief Executive Samantha Roberts said in a statement Tuesday . “We have done all we can to try and achieve that.” The UK’s National Health Service uses NICE’s recommendations to determine what treatments it pays for. It recommended against coverage of Enhertu earlier this summer, but kept negotiating with the companies. The UK group said that it and the country’s National Health Service tried to “offer as much flexibility as possible” but that the companies did not put forth “a cost-effective price.” Spokespeople for AstraZeneca and Daiichi didn’t immediately respond to a request for comment on NICE’s position. NICE compared the drug to Pfizer’s similar HER2-targeting cancer drug, Talzenna, for which it used the same assessment as Enhertu and ended up recommending it. Not recommending Enhertu breaks a streak of 21 consecutive positive recommendations for breast cancer treatments, NICE said. The decision was first handed down in July , after Enhertu became the first licensed product in the UK to treat the newly-defined HER2-low population. Those patients were previously categorized as HER2-negative, but have trace amounts of the protein. NICE estimates that there are about 1,000 women in England and Wales who would qualify for the drug. Enhertu is a rising star in AstraZeneca’s oncology portfolio, recording more than $1.4 billion in sales through the first nine months of the year. That includes $510 million in the third quarter , a 50% jump from the third quarter of 2023. None of AstraZeneca’s other cancer drugs saw greater revenue growth in the quarter.