Basilea Pharmaceutica Ltd announces that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the French Health Products Safety Agency (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS]).
Following the recommendation for regulatory approval under the European decentralized procedure, Toctino has received national regulatory approval in France. Basilea will submit a pricing and reimbursement dossier to the French authorities based on the approval.
Marketing applications for the use of alitretinoin in the treatment of severe chronic refractory hand eczema are also under regulatory review in Canada and in Switzerland.
Basilea Pharmaceutica Ltd is headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange.