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The FDA has accepted LEO Pharma's sNDA for delgocitinib cream for moderate-to-severe chronic hand eczema in adolescents.
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for delgocitinib (Anzupgo) cream for the treatment of moderate-to-severe chronic hand eczema (CHE) in adolescents aged 12 to 17 years.
"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, executive vice president and president of Region North America at LEO Pharma.
Announced on April 15, 2026 by LEO Pharma, the filing acceptance marks the first regulatory review pathway in the United States specifically targeting the pediatric age group for CHE. The announcement comes less than 1 year after delgocitinib cream became the first therapy to receive FDA approval for CHE in adults in July 2025.¹
The sNDA is supported by data from DELTA TEEN (NCT05355818), a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel-group, multicenter trial evaluating twice-daily applications of delgocitinib cream 20 mg/g versus cream vehicle in patients aged 12 to 17 years with moderate to severe CHE for whom topical corticosteroids were inadequate or inappropriate.¹
The primary endpoint was Investigator's Global Assessment for CHE treatment success (IGA-CHE TS) at week 16, defined as an IGA-CHE score of 0 or 1 with at least a 2-step improvement from baseline.¹ The trial met its primary endpoint and key secondary endpoints, with detailed efficacy and safety results presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress 2025.
Delgocitinib is a topical, non-steroidal pan-JAK inhibitor that suppresses JAK-STAT signaling, a pathway central to the inflammatory cascade implicated in CHE pathogenesis. LEO Pharma acquired exclusive rights to develop and commercialize delgocitinib for topical dermatological use outside Japan in 2014 while Shionogi & Co., Ltd. retains Japanese rights.
In adults, delgocitinib cream received FDA approval in July 2025 for moderate to severe CHE in patients who have had an inadequate response to, or for whom TCS are not advisable.² The product is also approved in the European Union, United Kingdom, Switzerland, Canada, Australia, South Korea, and the United Arab Emirates for the same adult indication.
The class-level safety profile of JAK inhibitors warrants attention in any new population. The US prescribing information for delgocitinib carries warnings regarding serious infections, non-melanoma skin cancer risk, and theoretical risks extrapolated from oral JAK inhibitor data, including cardiovascular mortality in higher-risk adults, but it is not established whether topical application confers equivalent systemic risk.² Common adverse effects reported with delgocitinib in adults include application site reactions, bacterial skin infections, and decreased white blood cell counts.²
FDA review timelines and a Prescription Drug User Fee Act (PDUFA) target action date were not disclosed in the announcement. The EMA review for the same indication is ongoing, but has not reached a regulatory decision.
