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news.Basilea Pharmaceutica has received marketing approval from the Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) for Toctino (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.
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Following the recommendation for regulatory approval under the European decentralised procedure, Toctino has received national regulatory approval in Italy and was accepted for reimbursement.
Basilea Pharmaceutica claimed that Toctino (alitretinoin) is the only therapy approved for severe chronic hand eczema unresponsive to potent topical treatments.
In a Phase III clinical trial program in CHE, Toctino showed effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50% of patients treated 30mg Toctino.
The once-daily oral therapy is given for 12 to 24 weeks, depending on patient response, and six-month post-treatment observations in patients who responded to Toctino indicate that treatment can provide long periods free from relapse and improve patient satisfaction.
In clinical trials, Toctino was well tolerated and demonstrated a safety profile overall consistent with the retinoid class.