Swiss biopharmaceutical company Basilea Pharmaceutica has reported that Toctino, a new once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, has obtained approval from the Spanish Drugs and Health Products Agency or Agencia Espanola de Medicamentos y Productos Sanitarios, AEMPS.
Following the recommendation for regulatory approval under the European decentralized procedure, Toctino has received national regulatory approval in Spain. Basilea will submit a pricing and reimbursement dossier to the Spanish authorities based on the approval.
Toctino has been launched in Denmark, Germany and the UK for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Launches in other European countries are expected during 2009.
Toctino has also received marketing authorization in Austria, Belgium, Finland, France, Luxemburg and the Netherlands. Further, Toctino has been recommended for approval in Italy. Alitretinoin is under regulatory review in Canada, Switzerland and 15 additional European countries.
Hans Christian Rohde, chief commercial officer of Basilea Pharmaceutica International, said: We are pleased by the AEMPS approval of Toctino, the first authorized oral treatment for patients suffering from severe chronic hand eczema who do not respond to potent steroid therapy. The disease heavily burdens patients’ ability to perform day-to-day activities and their psychological well-being. We look forward to bring this novel and effective treatment to patients and physicians in Spain.