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Basilea’s eczema drug wins EU recommendation for regulatory approval

Basilea Pharmaceutica has announced that Toctino, a new oral therapy for severe refractory chronic hand eczema, 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 favorable for use in adults who suffer from severe chronic hand eczema 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.

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.