US regulators have this week fast-tracked LEO pharma’s delgocitinib cream, an investigational topical pan-Janus kinase (JAK)-inhibitor, for the potential treatment of adults with moderate-to-severe chronic hand eczema (CHE).
There are currently no treatment options available in the US specifically developed and approved for the treatment of 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,” said Kim Kjøller, Executive Vice President of Global Research and Development of Denmark’s 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.”