LEO Pharma has taken a major step forward in its bid to commercialize Adtralza (tralokinumab) for moderate-to-severe atopic dermatitis after the European Medicines Agency recommended pan-EU marketing approval for the drug, which can be administered by health care professionals or by patients themselves.
Adtralza, an interleukin-13 inhibitor that is administered by injection, is not yet approved anywhere in the world. It is under regulatory review for moderate-to-severe atopic dermatitis in the US, with a decision from the Food and Drug Administration due later this year