The European Commission has approved tralokinumab for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. This was announced by Leo Pharma, underlining that the EU authorization makes tralokinumab “the first fully human high-affinity monoclonal antibody approved that binds and specifically inhibits the cytokine IL-13, a determinant of the signs and symptoms of atopic dermatitis”. The EC decision is valid in all EU Member States, Iceland, Norway and Liechtenstein. Further regulatory procedures are underway at the Medicines and Healthcare Products Regulatory Agency (Mhra) in the UK, the US Food and Drug Administration (Fda) and other bodies around the world. The EU green light – explains a note – is supported by data from clinical studies in which tralokinumab has been shown to significantly improve the signs and symptoms associated with atopic dermatitis, with stable response rates to treatment and gradually increasing over time. The drug is generally well tolerated, with a frequency and severity of adverse events comparable to those seen with placebo, and has been shown to reduce itching and improve overall health-related quality of life. Tralokinumab will be available in a 150 mg / mL pre-filled syringe format for subcutaneous injection to be administered in a starting dose of 600 mg, followed by 300 mg every other week. The therapy can be used either in combination with or without topical corticosteroids (Tcs). “By targeting the cytokine IL-13 with high affinity, tralokinumab has shown that it can reduce the signs and symptoms of atopic dermatitis and promote improvements over time,” says Stephan Weidinger, of the Department of Dermatology and Allergology at Schleswig University Hospital. Holstein from Kiel in Germany, who participated as an investigator in clinical trials on the drug. The approval – it is specified in the note – is mainly based on the safety and efficacy results emerging from pivotal phase III studies, Ecztra 1, 2 and Ecztra 3, which involved more than 1,900 adult patients with moderate to severe atopic dermatitis. The safety data was evaluated considering a pool of 5 randomized, double-blind, placebo-controlled studies, including Ecztra 1, 2 and Ecztra 3, one variable-dose and one vaccine response study. “Atopic dermatitis is a skin pathology affecting millions of adults throughout Europe with a strong impact on the quality of life – declares Paolo Pozzolini, VP & General Manager Leo Pharma Italy – The approval of tralokinumab by the European Commission is therefore an important step that will allow us to offer an important new therapeutic option for people with moderate to severe atopic dermatitis. And we are already working to make tralokinumab available and accessible to Italian patients soon. ”
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