Eli Lilly and Co. (LLY) Monday announced positive topline results from one-year analyses of Lebrikizumab Atopic Dermatitis Monotherapy trials. In these studies, patients treated with lebrikizumab maintained skin clearance and lasting relief from intense itch at one year.
With these data, Lilly plans to submit a Biologics License Application or BLA to the U.S. Food and Drug Administration for lebrikizumab in AD in the second half of 2022, followed by submissions to other regulatory agencies around the world.
Almirall, which has licensed the rights to develop and commercialize lebrikizumab in Europe, also plans to submit these results this year to the European Medicines Agency or EMA for authorization.
Atopic dermatitis or AD or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body. It is a complex disease that requires personalized treatment approaches, including flexible dosing options for patients.
Lebrikizumab is the company’s investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe AD.
The new findings from the Phase 3 ADvocate 1 and 2 clinical trials showed that eight out of ten patients who achieved clinical response with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen.
In addition, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period.
The company said these results build upon positive data from the 16-week, double-blind, placebo-controlled part of the ADvocate program.
The latest data supported both once every two week and once every four week maintenance dosing, with consistent and durable responses.
Full one-year results from the Phase 3 monotherapy studies will be disclosed at upcoming congresses and in publications in 2022. Additional Phase 3 clinical trials are enrolling for lebrikizumab in AD.
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