The European Medicines Agency (EMA) has accepted Almirall’s marketing authorisation application (MAA) filing for its lebrikizumab to treat moderate to severe atopic dermatitis (AD).
Characterised by recurrent inflammation of the skin associated with intense pruritus, AD is a non-contagious chronic, inflammatory disease of the skin.
Almirall has submitted the application based on data from three Phase III studies, including ADvocate 1 and ADvocate 2 as well as Adhere.
Both Advocate trials assessed lebrikizumab as monotherapy in adult and adolescent patients with moderate-to-severe AD, while Adhere evaluated lebrikizumab in combination with topical corticosteroids (TCS).
Lebrikizumab showed durable improvements in skin clearance and itch for patients in the maintenance phase of the two monotherapy trials. It also achieved efficacy with every four-week dosing.
Almirall chief scientific officer Karl Ziegelbauer said: “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.”
Almirall owns the rights to develop and commercialise lebrikizumab to treat dermatology indications, including AD, in Europe.
Eli Lilly and Company owns exclusive rights to develop and commercialise the therapy in the US and the remaining world excluding Europe.
The European approval is expected in the second half of next year.