FDA Accepts LEO Pharma's Delgocitinib Cream NDA for Chronic Hand Eczema Treatment

LEO Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for delgocitinib cream 20 mg/g (2%) for treating adults with moderate to severe Chronic Hand Eczema (CHE). This development is significant as there are currently no FDA-approved treatments for CHE, a condition that impacts patients' daily lives due to its symptoms of itch and pain. LEO Pharma is committed to addressing this unmet need and providing new treatment options for adults in the U.S., following similar regulatory milestones in other regions, including recent approval from the European Commission (EC) for delgocitinib cream in the European Union (EU).

The regulatory submission for delgocitinib cream is supported by results from the phase 3 clinical trials, DELTA 1 and DELTA 2, which evaluated the safety and efficacy of the cream. Both trials successfully met their primary and secondary endpoints. Participants who completed the initial 16-week trials were given the option to enroll in a 36-week open-label extension trial (DELTA 3) to further assess the long-term safety of the treatment.

Delgocitinib cream is an investigational topical pan-Janus kinase (JAK) inhibitor designed to inhibit JAK-STAT signaling, a crucial pathway in the pathogenesis of CHE. JAK-STAT signaling is associated with skin barrier dysfunction, inflammation, and alterations in the skin microbiome, all of which contribute to the condition's severity.

Dr. Christopher Bunick, an Associate Professor of Dermatology at Yale Medical School, highlighted the significant impact of CHE on patients' lives, emphasizing the need for more treatment options beyond traditional topical corticosteroids. The acceptance of the NDA for delgocitinib cream brings hope for a new potential treatment for those affected by this debilitating condition in the U.S.

Chronic Hand Eczema is a fluctuating inflammatory skin disease characterized by symptoms such as itch and pain, skin barrier dysfunction, inflammation, and microbiome changes. It can lead to significant psychological, social, and occupational burdens, affecting patients' quality of life and mental well-being. The prevalence of CHE is approximately 4.7%, with a considerable proportion of patients experiencing chronic symptoms that disrupt daily activities and impact careers and earning potential.

Brian Hilberdink, EVP and President of LEO Pharma's North America Region, expressed the company's commitment to addressing the high unmet need for CHE treatments in the U.S. He noted that the filing of the NDA for delgocitinib cream validates LEO Pharma's mission to advance the standard of care in dermatology. The company plans to work closely with the FDA during the review process, which is expected to conclude in the second half of 2025.

The DELTA 1 and DELTA 2 trials were randomized, double-blind, vehicle-controlled, multicenter phase 3 studies that aimed to evaluate the efficacy of twice-daily applications of delgocitinib cream compared to a placebo cream vehicle in adults with moderate to severe CHE. The primary endpoint was treatment success, defined by an Investigator’s Global Assessment (IGA) score indicating a clear or almost clear condition with significant improvement from baseline. Secondary endpoints included reductions in itch and pain scores and improvements on the Hand Eczema Severity Index (HESCI).

Subjects completing the initial trials could participate in the DELTA 3 extension trial to continue evaluating the treatment's long-term safety. The study aimed to provide further insights into the potential benefits and risks associated with prolonged use of delgocitinib cream for CHE.

LEO Pharma's dedication to dermatology and skin condition treatments is reflected in their extensive research and development efforts. Founded in 1908 and majority-owned by the LEO Foundation, the company operates globally, with a team of 4,200 people serving millions of patients. In 2023, LEO Pharma reported net sales of DKK 11.4 billion, underscoring their significant presence in the healthcare industry.