EMA Accepts Filing of MAA for Almirall's Lebrikizumab in AD

October 28, 2022
EMA Accepts Filing of MAA for Almiralls Lebrikizumab in AD image

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world, not including Europe.

The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for Almirall’s lebrikizumab for the treatment of moderate to severe atopic dermatitis.

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity, slow disassociation rate and high potency to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signalling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. AD is an IL-13 dominant disease in which IL-13 drives skin barrier dysfunction, itch, skin thickening, and susceptibility to infection.

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.

“Today marks the first step of the regulatory process in Europe of lebrikizumab, which we believe it has the potential to become a best-in-class treatment for atopic dermatitis. Upon approval by the EMA, patients with AD would have a new treatment option with a favourable safety and efficacy profile. At Almirall, we continue to work towards the market launch of this potential breakthrough treatment with the aim of fulfilling our purpose of improving patients' lives”, says Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer, in a news release.

Here, Jaccob Thyssen, MD, PhD, DmSci, a professor at the University of Copenhagen and a dermatologist at Bispebjerg Hospital in Denmark, discusses the latest data on lebrikizumab from the 31st EADV Congress in Milan, Italy.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of lebrikizumab in the United States and the rest of the world, not including Europe.

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