European Commission approves EU’s first AD biologic for marketing authorisation

European approval for Pfizer’s psoriatic arthritis combo
Credit: Hriana

The European Commission has granted marketing authorisation for Dupixent for use in adults with moderate-to-severe atopic dermatitis, Sanofi and Regeneron have confirmed.

This approval marks the first targeted biologic in the European Union to receive marketing authorisation for use in atopic derma (AD).

AD – a form of eczema – is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.

“People with moderate-to-severe atopic dermatitis can experience unbearable symptoms that may significantly impact their quality of life,” said Christine Janus, CEO of the International Alliance of Dermatology Patient Organizations.

“Many often struggle to control their disease with the treatment options currently available.”

She added: “We support timely access to this important new medication.”

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signalling of two key proteins – IL-4 and IL-13 – which are believed to be major drivers of the persistent underlying inflammation in AD.