Basilea Pharmaceutica Ltd announces that Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has been approved by the Danish Medicines Agency (DKMA).
Following the recommendation for regulatory approval under the European decentralized procedure, Toctino received national regulatory approval in Denmark.
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.
Hand eczema is a common inflammatory skin disease and is often chronic and relapsing.
Toctino (alitretinoin) was developed by Basilea Pharmaceutica International Ltd. It (alitretinoin) is a convenient once-daily capsule to be taken with food. The recommended starting dose is 30 mg in most patients and a treatment course lasts up to 24 weeks depending on response.
Basilea is headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's integrated research and development operations are currently focused on new antibacterial and antifungal agents to fight drug resistance and on the development of dermatology drugs.