Basilea Pharmaceutica Ltd. has announced the submission of a Marketing Authorization Application (MAA) for Toctino (alitretinoin) in 13 additional European Union (EU) Member States as well as in Norway and Iceland. Toctino is a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.
The MAA for Toctino was submitted under the Repeat Use Procedure to various EU Member States and European countries and supports the proposed use of oral alitretinoin in adults with severe chronic hand eczema that is unresponsive to potent topical corticosteroids.
"It is important for us to make Toctino available across Europe for physicians to treat patients with this chronic debilitating disease. Our submission in 15 additional European countries is a key step towards this goal," said Dr. Anthony Man, CEO Basilea Pharmaceutica Ltd. "Furthermore, pending local approval of this second wave of Marketing Authorization Applications, we are exploring options for third-party distribution of this innovative medicine in some of these countries."
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities.
Toctino (alitretinoin), the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids
Toctino was developed by Basilea Pharmaceutica International Ltd. To date, Toctino is launched in Denmark, Germany and the United Kingdom, and has received marketing authorization in Austria, Belgium, Finland, France and Luxemburg. In addition, Toctino has been recommended for approval in three additional EU Member States and is under regulatory review in Switzerland and Canada.