EU Thumbs Up Signals First-Ever Approval For Leo’s Tralokinumab

UK Regulator Also Expected To Reach Decision On Approval Soon

Leo’s moderate-to-severe atopic dermatitis drug is set to be approved for the first time worldwide.

A new atopic dermatitis drug is on track to win EU approval • Source: Alamy

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...