FDA Fast Tracks Leo Pharma’s Delgocitinib Cream for Hand Eczema

 Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.

Delgocitinib cream, Leo Pharma’s investigational topical pan-Janus kinase (JAK)-inhibitor, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of adults with moderate-to-severe chronic hand eczema (CHE).

There are currently no treatment options available in the U.S specifically for CHE.

Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases. The cream formulation of delgocitinib is not currently approved by any regulatory authorities.

“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, Global Research and Development, LEO Pharma, in a news release. “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.”

LEO Pharma recently completed a multi-center, randomized Phase 2b clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe CHE and a Phase 2b clinical trial with twice-daily topical delgocitinib cream for the treatment of adults with mild-to-severe atopic dermatitis (AD). LEO Pharma plans to submit the key results of the CHE Phase 2b study for publication later this year.