Basilea Pharmaceutica Ltd announces that Toctino (alitretinoin), a new oral therapy for severe refractory Chronic Hand Eczema (CHE), was recommended for regulatory approval under the European decentralized procedure and will become the first authorized treatment for this chronic disabling disease.
The concerned EU Member States concluded that the profile of Toctino (alitretinoin) is favourable for the use in adults who suffer from severe CHE that is unresponsive to treatment with potent topical corticosteroids. The recommendation for approval is the final step before national marketing licenses are granted.
Subject to approval by the individual EU Member States alitretinoin is expected be marketed under the trade name Toctino.
Dr Anthony Man, CEO of Basilea said, "We are absolutely delighted to receive an approval recommendation from the eleven EU Member States that were included in the procedure. Subject to national approval we will offer the first authorized oral treatment for patients suffering from severe CHE who do not respond to potent steroid therapy. CHE is a disease that heavily burdens patients' professional life and psychological well-being. This is also a great moment in the history of our company as we start launching Toctino in the European market."
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.
CHE is a common inflammatory skin disease and is often chronic and relapsing. It is one of the most common occupational skin diseases and a frequent reason for patients to consult a dermatologist. Hand eczema is reported to affect up to ten per cent of the general population. The more severe, chronic form of the condition is thought to affect up to seven per cent of these patients, many of whom do not respond, or no longer respond to potent topical steroids.