The European Medicines Agency (EMA) has approved Almirall’s filing of a Marketing Authorization Application (MAA) to use lebrikizumab to treat patients with moderate-to-severe atopic dermatitis.

The MAA is based on three pivotal phase 3 studies: ADvocate 1, ADvocate 2 and ADhere.

The first two studies listed above assessed lebrikizumab as a single therapy for adult and adolescent patients with moderate-to-severe atopic dermatitis, while the third trial listed above assessed lebrikizumab as a combination treatment with topical corticosteroids (TCS).

In the maintenance phase of ADvocate 1&2, lebrikizumab showed significant improvements in skin clearance and itch for patients who achieved a clinical response after 16 weeks of treatment up until one year.

In addition, the results demonstrated efficacy with every four-week dosing – following a 16-week induction period with lebrikizumab every two weeks – was similar to the efficacy reported for every two-week dosing.