Basilea’s Toctino Receives Recommendation For Approval In 15 European Countries

Basilea Pharmaceutica has announced that Toctino (alitretinoin) was recommended for regulatory approval under the repeat-use procedure in 13 additional EU Member States as well as in Norway and Iceland. Toctino is a once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.

Dr Anthony Man, CEO of Basilea Pharmaceutica, said: “We are very pleased about the recommendation for approval from the 15 European countries that were included in the procedure. Subject to national approval and price and reimbursement decisions, the availability of Toctino for patients and physicians will continue to expand across Europe.”

The various EU Member States and European countries concluded that the profile of Toctino is favorable for the use in adults, who suffer from severe CHE that is unresponsive to treatment with potent topical corticosteroids.

Moreover, Toctino has been launched in Denmark, France, Germany and the UK for the treatment of adults with severe chronic hand eczema unresponsive to potent topical corticosteroids. Toctino has also received marketing authorisation in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands, Spain and Switzerland. Further, Toctino has been recommended for approval in 16 European countries.