Basilea's Toctino receives marketing authorization in Belgium and Luxemburg

12-Mar-2009 - Belgium

Basilea Pharmaceutica Ltd. announced that Toctino® (alitretinoin), a once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the health authorities in Belgium (Agence Fédérale des Medicaments et des Produits de Santé [AFMPS]) and in Luxemburg (Ministère de la Santé [MS]).

Subsequent to the recommendation for regulatory approval under the European decentralized procedure, Basilea received the marketing authorization for Toctino® in Belgium and Luxemburg. Following the regulatory approval of Toctino® in Belgium and Luxemburg, Basilea will submit a pricing and reimbursement dossier to the country authorities. The Belgian AFMPS and the MS in Luxemburg approved Toctino® for the use in adults who have severe CHE that is unresponsive to treatment with potent topical corticosteroids.

Toctino® is a once-daily oral therapy for the treatment of adults that is given for 12 to 24 weeks, depending on patient response. In the six-month post-treatment observation in the pivotal phase III clinical trials, patients who responded to Toctino® experienced long periods free from relapse and improved patient satisfaction. Toctino® has been launched in Denmark, Germany and the United Kingdom and has also received marketing authorization in Finland and France. It has also been recommended for approval in four additional EU Member States and is under regulatory review in Canada and Switzerland.

In the largest ever phase III clinical trial program in CHE, Toctino® was the first treatment able to show effective clearing of severe CHE unresponsive to potent topical corticosteroids, with clear or almost clear hands achieved in nearly 50 percent of patients treated with 30 mg Toctino®.

https://www.bionity.com/en/news/98168/basilea-s-toctino-receives-marketing-authorization-in-belgium-and-luxemburg.html