The approval of this IL-13 blocker in the European Union is expected in approximately two months and its launch in the first European country could take place soon after. 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Almirall's EBGLYSS (lebrikizumab) for the treatment of adult and adolescent patients aged 12 and older with a body weight of at least 40 kg who have moderate-to-severe atopic dermatitis and are candidates for systemic therapy.

Now, the positive CHMP opinion is 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. 

Lebrikizumab is an investigational monoclonal antibody that binds to IL-13 protein with high affinity and inhibits its downstream signaling 

The positive opinion is based on Phase 3 studies which showed long-term response in skin clearance and itch control . Specifically, most patients (80%) 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.

“Lebrikizumab’s … monthly maintenance dosing regimen offers convenience and flexibility, benefiting both patients and healthcare providers,” says  Prof. Alan Irvine, a dermatologist in Children’s Health Ireland and St. James’s Hospital, Dublin & Professor in Dermatology, Trinity College Dublin, in a news release. “The potential inclusion of this treatment in the range of options against atopic dermatitis means a significant stride toward enhancing the quality of life of individuals struggling with this challenging skin condition.” 

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland in 2024.

The U.S. Food and Drug Administration could approve lebrikizumab by mid-2023, according to media reports.