Almirall’s lebrikizumab has been granted approval by the European Medicines Agency (EMA) for its filing of a Marketing Authorization Application (MAA) for use as a treatment in patients with moderate-to-severe atopic dermatitis (AD).
The MAA is based on three pivotal phase 3 studies: ADvocate 1, ADvocate 2 and ADhere.
ADvocate 1 and ADvocate 2 assessed lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe AD, while the ADhere trial assessed lebrikizumab as a combination treatment with topical corticosteroids (TCS).
In the maintenance phase of ADvocate 1&2, lebrikizumab showed significant and durable improvements in skin clearance and itch for patients who achieved a clinical response at week 16 through one year of treatment.
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.
Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity, slow disassociation rate and high potency, in order to prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and the signalling that follows, which blocks the biological effects of IL-13 in a targeted manner. This is vital in AD, as the condition is a IL-13 dominant, with IL-13 acting as the central driver to skin barrier dysfunction, itch, skin thickening and the skin’s susceptibility to infection.
“[This approval] marks the first step of the regulatory process in Europe of lebrikizumab, which we believe has the potential to become a best-in-class treatment for AD. Upon approval by the EMA, patients with AD would have a new treatment option with a favourable safety and efficacy profile,” stated Karl Ziegelbauer, Almirall’s chief scientific officer.
Almirall has licensed the rights to develop and commercialise lebrikizumab for use as a treatment of dermatology indications, including AD, in Europe, while Eli Lilly has exclusive rights for the development and commercialisation of lebrikizumab in the US and the rest of the world, but not including Europe.
AD – also known as atopic eczema – is a non-contagious chronic, inflammatory skin disease which presents in a recurrent inflammation of the skin, associated with severe itching. As well as the physical pain AD can cause, this condition can have severe emotional effects that can have a big impact on the academic, social, and/or work life of patients with AD.
In the EU, up to 4.4% of adults are affected, and the prevalence of AD appears to have increased over the past decades, with approximately 30% of adult patients diagnosed as having moderate-to-severe disease.