Basilea Pharmaceutica Ltd announces that Toctino (alitretinoin) was recommended for regulatory approval under the Repeat-use Procedure in 13 additional European Union (EU) Member States as well as in Norway and Iceland. Toctino is a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.
"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," said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd.
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. The recommendation for approval is the final step before national marketing licenses are granted.