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news.Basilea Pharmaceutica has announced that the marketing authorization application for alitretinoin that was submitted to various EU member states has been accepted for review. The application supports the proposed use of oral alitretinoin in patients with severe refractory chronic hand eczema.
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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.