CHMP positive for Ebglyss for the treatment of adult and adolescent patients with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy
Almirall S.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of Ebglyss (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy.
The positive CHMP opinion is now being reviewed by the European Commission (EC). The approval of this biologic in the European Union is expected in approximately two months and its launch in the first European country could take place soon after.
Results from the Phase III clinical development program showed most patients (80 percent) who responded to treatment with lebrikizumab at Week 16 weeks maintained skin clearance and itch relief through one year of treatment with monthly maintenance dosing.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.