The marketing authorization application seeks approval for oral alitretinoin for the treatment of severe refractory chronic hand eczema (CHE) and is based on a clinical program comprising almost 2,000 patients. A market authorization application for alitretinoin in severe refractory CHE was recently submitted to the Swiss health authority Swissmedic.
Hand eczema is a common skin disease and is often chronic and relapsing. It is estimated to affect up to 10% of the general population. The more severe, chronic form of the condition is thought to affect up to 7% of these patients, many of whom do not respond, or no longer respond to topical corticosteroids. Basilea estimates there are at least 500,000 patients in Europe with refractory severe CHE.