EMA Accepts LEO Pharma’s Marketing Authorization Application (MAA) for Delgocitinib Cream in Chronic Hand Eczema (CHE)

BALLERUP, Denmark, August 18 – LEO Pharma A/S announces today that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for delgocitinib cream, an investigational product and topical pan-Janus kinase (JAK) inhibitor for the treatment of adult patients with moderate to severe chronic hand eczema (CHE). The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“We are delighted that delgocitinib cream has entered this first stage of the European regulatory process. If approved, it will be the first topical treatment specifically indicated and developed for moderate to severe CHE,” says Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma and points to the company’s dedication to advancing the standard of care for the benefit of people with skin conditions, their families, and society.

 

Critical unmet need

“Chronic hand eczema negatively impacts patients’ quality of life, psychological well-being, physical functioning, and ability to work. Despite a one-year prevalence of around 9%, there are currently no topical treatments specifically approved for the treatment of moderate to severe CHE. The strong clinical data enclosed in this submission brings hope to patients and reflects LEO Pharma’s continued commitment to addressing the critical unmet need in CHE,” says Dr Jacob Pontoppidan Thyssen, Executive Vice President and Chief Scientific Officer, LEO Pharma.

First-in-class investigational topical treatment for CHE

LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe CHE in adults. CHE is a heterogenous, fluctuating, inflammatory skin disease with key symptoms of itch and pain, with a high psychological, social, and occupational burden, that warrants specifically developed treatments.^1-3 There are currently no treatments specifically approved for moderate to severe CHE that provide both short-term efficacy and long-term disease control.¹ Delgocitinib cream is a first-in-class investigational topical pan-JAK inhibitor for CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.⁴ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁵

The MAA for delgocitinib cream is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 phase 3 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle.^6,7 Both trials met their primary and all secondary endpoints.^8,9 The MAA is also based on interim data from the DELTA 3 open-label, multi-site extension trial, which is still in progress and is evaluating the long-term safety of delgocitinib cream.¹⁰ The efficacy and safety of delgocitinib cream have not been evaluated by any regulatory authority.

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About the DELTA 1, 2 and 3 Trials

The primary objective for the randomized, double-blind, vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1 and DELTA 2) was to evaluate the efficacy of twice-daily applications of delgocitinib cream compared with cream vehicle in the treatment of adults with moderate to severe CHE.^6,7

The primary endpoint of the trials 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. Additional IGA-CHE scores included 2 (mild), 3 (moderate), and 4 (severe).

Key secondary endpoints at Week 16 included reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD) from baseline to Week 16, as well as at least 75% improvement from baseline and at least 90% improvement from baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The number of treatment-emergent adverse events from baseline to Week 16 defined the key safety endpoint of the trials.

Subjects who completed 16 weeks of treatment with delgocitinib cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2 were offered to roll-over to the DELTA 3 Open-label, Multi-site Extension trial. The purpose of this ongoing extension trial is to evaluate the long-term safety of delgocitinib.¹⁰

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.^11,12 HE is the most common skin disorder of the hands¹³ with a one-year prevalence rate of approximately 9%.¹⁴ In a substantial number of patients, HE can develop into a chronic condition.¹³ CHE is a fluctuating disease with key symptoms being itch and pain, and patients may experience signs such as erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on hands and wrists.¹

About delgocitinib

Delgocitinib is a first-in-class investigational topical pan-Janus kinase (JAK) inhibitor. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.⁴ The pathophysiology is characterized by skin barrier dysfunction, inflammation of the skin, and alterations of the skin microbiome.⁵  LEO Pharma is currently developing delgocitinib in a cream formulation for the treatment of moderate to severe chronic hand eczema (CHE) in adults. 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.