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 German health authority "Bundesinstitut für Arzneimittel und Medizinprodukte" (BfArM).
Following the recommendation for regulatory approval under the European decentralized procedure, Toctino received national regulatory approval in Germany.
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. 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 percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients. CHE causes significant economic and occupational burden with total costs alone in Europe estimated to eleven billion Euro per year. The most important patient burden is impaired use of the hands and a considerable impact on patients' quality of life.
Toctino (alitretinoin) was developed by Basilea Pharmaceutica International Ltd.
The BfArM approved Toctino for the use in adults who have severe CHE that is unresponsive to treatment with potent topical corticosteroids.
Patients whose CHE is predominantly characterized by fissured, thick scaly skin are more likely to respond than those in whom the eczema is mainly characterized by blisters.
Toctino (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.
Alitretinoin belongs to the well studied family of retinoids. All retinoids are teratogens. Therefore pregnancy is a contraindication to alitretinoin therapy and strict pregnancy prevention measures must be in place for all women of child-bearing potential who receive alitretinoin. A comprehensive pregnancy prevention program has been developed and implemented. In clinical trials alitretinoin was well tolerated and has a safety profile overall consistent with the retinoid class. Side effects were generally dose-dependent and reversible.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland. 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.