EMA accepts Almirall's filling for lebrikizumab in atopic dermatitis

The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis submitted by Almirall (BME: ALM), the Spanish dermatology firm announced this morning.

The MAA filing is based on three pivotal Phase III studies. Advocate 1 and Advocate 2, evaluating lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe AD, and ADhere, assessing lebrikizumab in combination with topical corticosteroids (TCS). In the maintenance phase of the two monotherapy trials (Advocate 1 & 2), lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response at Week 16 through one year of treatment. Results also demonstrated efficacy with every four-week dosing - after a 16-week induction period with lebrikizumab every two weeks - was similar to the efficacy observed for every two-week dosing.

Rival option in AD