FDA grants delgocitinib fast track designation for chronic hand eczema

August 5, 2020

The U.S. Food and Drug Administration (FDA) has granted JAK-inhibitor delgocitinib cream (LEO Pharma) Fast Track Designation for chronic hand eczema.

The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to delgocitinib cream (LEO Pharma) for the treatment of adult moderate-to-severe chronic hand eczema (CHE).

Delgocitinib cream, a topical pan-Janis kinase (JAK)-inhibitor, works by blocking activation of the JAK-STAT pathway, which is a known contributor to the pathophysiology of chronic inflammatory skin diseases. Currently, the cream is the only treatment in development specifically for CHE in the Unites States.

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CHE is described as hand eczema lasting more than three months or relapsing twice or more within a year. CHE can cause swelling, itching, blisters and severe pain, according to the press release.1

Most recently, LEO Pharma completed a phase 2b, 16-week, randomized, double-blind, vehicle-controlled, dose-ranging clinical trial investigating the safety and efficacy of delgocitinib 1, 3, 8 and 20 mg/g twice daily in adult patients with mild-to-severe CHE.2 The results will be published later this year, according to the company.

“Moderate-to-severe CHE can be a disabling skin disease that can disrupt the ability for people to work and be self-sufficient because their hands can feel so raw and painful,” says Kim Kjøller, M.D., executive vice president of global research and development at LEO Pharma. “We are delighted that topical delgocitinib cream has been granted Fast Track designation and look forward to collaborating with the FDA during the development process as we aim to accelerate bringing this potential new treatment option to patients."

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Delgocitinib cream is the result of a license agreement between LEO Pharma and Japan Tobacco Inc. in 2014, which gave LEO Pharma exclusive rights to develop and commercialize the topical worldwide, except in Japan.1

References:

1. LEO Pharma Announces U.S. Food and Drug Administration Fast Track Designation for delgocitinib Cream for the Treatment of Adults With Moderate-to-severe Chronic Hand Eczema. https://www.businesswire.com/news/home/20200804005556/en/LEO-Pharma-Announces-U.S.-Food-Drug-Administration. Published August 4, 2020. Accessed August 5, 2020.

2. Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema - Full Text View. Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema. https://www.clinicaltrials.gov/ct2/show/NCT03683719?cond=NCT03683719. Published June 9, 2020. Accessed August 5, 2020.