The European Commission has approved Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.
The European approval makes Adtralza the first high affinity, fully human monoclonal antibody approved to specifically bind to and inhibit the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms, states the company in a press release.
The ECZTRA 1, 2 and ECZTRA 3 Phase 3 trials
The approval is based primarily on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis. Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-ranging trial, and a vaccine response trial.
“This European Commission approval of Adtralza is an important development for the millions of adults in Europe who are living with this often uncontrolled skin disease,” says Catherine Mazzacco, President and CEO of LEO Pharma. “We are proud to have the opportunity to offer a new long-term treatment option for moderate-to-severe atopic dermatitis and are working closely with key stakeholders to enable access to Adtralza for eligible patients.”
Photo of Catherine Mazzacco: LEO Pharma