Swiss biopharmaceutical company Basilea Pharmaceutica has received approval from the Dutch Medicines Evaluation Board for Toctino, a new once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids.
Subsequent to the recommendation for regulatory approval under the European decentralized procedure, Basilea received the marketing authorization for Toctino in Netherlands. Following the regulatory approval of Toctino in Netherlands, Basilea will submit a pricing and reimbursement dossier to the country authorities.
Toctino has been launched in Denmark, Germany and the UK, and has also received marketing authorization in Austria, Belgium, Finland, France and Luxemburg, said Basilea. In addition, Toctino has been recommended for approval in two additional EU member states and is under regulatory review in Switzerland, Canada and 15 additional European countries, the company noted.
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, said Basilea.
In a Phase III clinical trial program in chronic hand eczema (CHE), Toctino was the first treatment to show effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50% of patients treated with 30mg Toctino, according to Basilea. A Phase III clinical trial on alitretinoin for the treatment of severe CHE is ongoing in the US.