BRIEF—LEO Pharma wins Japanese approval for Adtralza

Denmark’s LEO Pharma has won approval in Japan for Adtralza (tralokinumab) subcutaneous injection, for adults with atopic dermatitis in the second-line setting.

Marketed in the USA as Adbry, the product is the only approved monoclonal antibody developed to specifically target and neutralize the interleukin (IL)-13 cytokine, which plays a key role in the pathology of atopic dermatitis.

Kook Hyun Son, general manager of the firm’s Japanese business, said LEO had made “substantial investments in our infrastructure, including the hiring of dedicated medical staff to ensure dermatologists receive the latest Adtralza clinical information to help inform treatment decisions for their patients.”

The company said it would continue to evaluate regulatory filings in markets “where there is the greatest need,” to widen access to the therapy.

The decision was made based on data from the Phase III ECZTRA 8 trial, which took place in Japan.