EU regulators have accepted for review LEO Pharma's tralokinumab for the treatment of moderate-to-severe atopic dermatitis.
The drug is a fully human monoclonal antibody that specifically neutralises the interleukin-13 (IL-13) cytokine – a key driver of the underlying inflammation in AD.
The marketing application is based on data from the pivotal ECZTRA 1, 2 and 3 Phase III studies evaluating the efficacy and safety of tralokinumab.
In trials, the drug demonstrated clear or almost clear skin at week 16 and at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16.
In addition, it showed a change in baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD) and overall adverse event rate was comparable to placebo.
“People living with atopic dermatitis often face tremendous physical, social and emotional challenges,” said Kim Kjøller, executive vice president, Global Research and Development, at LEO Pharma.
“Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden.”