LEO Pharma Announces FDA Acceptance of Supplemental NDA for ANZUPGO® (delgocitinib) Cream for the Treatment of Chronic Hand Eczema in Children Aged 12-17
LEO Pharma Inc., a global leader in medical dermatology, today announced that the U.S. FDA accepted its supplemental New Drug Application (sNDA) for ANZUPGO®(delgocitinib) cream for the treatment of pediatric patients aged 12 to 17 years with moderate to severe chronic hand eczema (CHE). ANZUPGO cream is a topical and non-steroidal pan-Janus kinase (JAK) inhibitor currently approved in the U.S. for the treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to topical corticosteroids (TCS), or for whom TCS are not advisable.
“Pediatric patients living with chronic hand eczema currently have no approved treatment options specifically indicated for CHE, representing a significant unmet medical need,” said Bob Spurr, EVP and President, Region North America, LEO Pharma. “As LEO Pharma continues to expand its presence in the U.S., we are committed to investing in the development and advancement of treatments like ANZUPGO, which is the only approved treatment specifically for chronic hand eczema in adults and, if approved for pediatric patients, could help address this important gap in care.”
The potential expansion of the label builds on existing approvals for adult patients in the U.S2 and other regions3, and is reinforcing LEO Pharma’s commitment to advancing care for underserved patient populations. The safety and efficacy of ANZUPGO in pediatric patients aged 12-17 have not been fully evaluated by the FDA.
Pediatric patients with CHE can experience symptoms such as itchy, painful, blistered, or swollen skin that may interfere with daily activities4. Pediatric CHE remains an underserved disease with a lack of pediatric-specific CHE guidelines4, no approved treatment options specifically indicated for pediatric CHE, and limitations of long-term and repetitive topical corticosteroids (TCS) use. 5-8 These challenges highlight the need for timely intervention and approved, non-steroidal topical treatments to help address the unmet needs of pediatric patients with CHE.
“We are incredibly excited to have taken this step in hopefully providing a new treatment for pediatric patients currently lacking options specifically indicated for CHE in the US, said Sophie Lamle, Executive Vice President, Development at LEO Pharma. “For pediatric patients living with chronic hand eczema, the disease can affect them at a formative time in their lives and personal development. The FDA’s acceptance to review this filing brings us one step closer to potentially offering a much-needed treatment option for this underserved population.”
The label expansion application is based on data from DELTA TEEN, a phase 3 trial with ANZUPGO (delgocitinib) 20mg/g cream that investigated the efficacy and safety of twice-daily applications of ANZUPGO compared with cream vehicle in pediatric patients aged 12-17 years with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.1 The trial met the primary endpoint and key secondary endpoints, and the detailed results were presented as a late breaking presentation at European Academy of Dermatology and Venereology (EADV) 2025 in Paris, France.9
Currently, ANZUPGO is approved for adults in the United States, the European Union, the United Kingdom as well as several other markets for the treatment of moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate. ANZUPGO is currently also being reviewed by the European Medicines Agency for adolescents aged 12-17 years with moderate to severe CHE.
About the DELTA TEEN Trial
DELTA TEEN was a 16-week, phase 3, randomized, double-blind, cream vehicle-controlled, parallel group, multi-site trial to evaluate the efficacy and safety of twice-daily applications of ANZUPGO compared with cream vehicle in pediatric patients 12-17 years of age with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.1,9
The primary endpoint of DELTA TEEN was the Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16. Treatment success was defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a two-step improvement from baseline.1,9
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. 10 CHE is one of the most common skin diseases of the hands and wrists and affects approximately one in ten adults worldwide. 11–14 In a substantial number of patients, HE can develop into a chronic disease. 13 CHE is a fluctuating disease characterized by itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists. 15
CHE has been shown to cause psychological and functional burdens that impact patient quality of life, 16,17 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. 18 Furthermore, careers and earning potential have also been shown to be impacted by the burden of living with CHE. 19
About ANZUPGO® (delgocitinib) Cream
ANZUPGO cream is a topical and non-steroidal pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.20
ANZUPGO (delgocitinib) cream is FDA approved in the U.S. for moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended by the U.S. FDA.2
ANZUPGO is approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the treatment of moderate to severe Chronic Hand Eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate.1 ANZUPGO cream is also under investigation in other markets.
In 2014, LEO Pharma obtained the exclusive rights to develop and commercialize delgocitinib for topical use in dermatological indications worldwide, excluding Japan, where Shionogi & Co., Ltd. owns the rights.
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