Japanese MHLW approves Adtralza for atopic dermatitis.- LEO Pharma

The approval is based on results from the global pivotal trials ECZTRA 1, 2, and 3 the Japanese pivotal trial ECZTRA 8, and the global open-label extension trial ECZTEND.

ECZTRA 8 was a 16-week, double-blind, randomized, placebo-controlled phase III study in Japanese patients. The study evaluated the efficacy and safety of tralokinumab (300 mg) in combination with TCS in 106 adult patients with atopic dermatitis who were candidates for systemic therapy having an inadequate response to existing therapy. ECZTEND (Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous tralokinumab Trials) is an ongoing Phase III, long-term five-year, open-label, single-arm extension trial to evaluate the efficacy and safety of tralokinumab in patients with atopic dermatitis who participated in the previous tralokinumab monotherapy trials (ECZTRA 1 and ECZTRA 2), the combination therapy tralokinumab plus TCS trial (ECZTRA 3), the Drug-drug interaction (DDI) trial (ECZTRA 4), the vaccine trial (ECZTRA 5), the adolescent trial (ECZTRA 6), the oral cyclosporine A trial (ECZTRA 7), the combination therapy tralokinumab plus TCS trial in Japanese subjects (ECZTRA 8), and the tralokinumab monotherapy skin barrier function trial (TraSki). Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with tralokinumab or placebo.