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news.Basilea Pharmaceutica, a Switzerland-based R&D biopharmaceutical company, has received approval from the Austrian Agency for Health and Food Safety for Toctino, a new once-daily oral treatment for adults with severe chronic hand eczema unresponsive to potent topical corticosteroids.
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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, the company said.
Subsequent to the recommendation for regulatory approval under the European decentralized procedure, Basilea received the marketing authorization for Toctino in Austria. Following the regulatory approval of Toctino in Austria, 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 Belgium, Finland, France and Luxemburg. It has also been recommended for approval in three additional EU member states and is under regulatory review in Canada and Switzerland.