CHMP Recommends Marketing of Biologic for Atopic Dermatitis
Doug Brunk
September 15, 2023
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization of lebrikizumab for the treatment of adult and adolescent patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Lebrikizumab is an investigational, monoclonal antibody that binds to cytokine interleukin (IL)-13, which has been implicated in driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection. The biologic is being developed by Almirall and is designed to be administered once per month. Lebrikizumab is not yet available in the United States.
According to a press release from Almirall, the CHMP opinion was based on three pivotal phase 3 studies that showed long-term response in skin clearance and itch control. ADvocate 1 and ADvocate 2 evaluated lebrikizumab as monotherapy, while ADhere assessed lebrikizumab in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate to severe AD. At week 16, more than 50% of patients with moderate to severe AD experienced at least a 75% reduction in disease severity (EASI-75) when receiving lebrikizumab monotherapy in the ADvocate studies and nearly 70% of patients receiving lebrikizumab combined with standard-of-care TCS achieved EASI-75 in the ADhere trial.
Most adverse events across the studies were mild or moderate. The most common reactions were conjunctivitis, injection site reactions, allergic conjunctivitis, and dry eye.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.