EMA Validates MAA for Leo Pharma’s Tralokinumab

Leo Pharma, medical dermatology specialist, has announced, in a June 11, 2020 press release, that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for tralokinumab.

Tralokinumab is an investigational, fully human, immunoglobin G4 monoclonal antibody for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD). EMA’s decision to validate the MAA for tralokinumab has been based on data from ECZTRA 1,2, and 3 Phase III studies, which evaluated the efficacy and safety of the treatment as monotherapy.

“People living with atopic dermatitis often face tremendous physical, social, and emotional challenges,” said Kim Kjøller, executive vice-president, Global Research and Development, LEO Pharma, in the press release. “Since atopic dermatitis is a heterogeneous disease, we are focused on targeted therapies with the potential to treat individual needs and reduce this burden. We look forward to working closely with EMA as they review this application.”

Source: Leo Pharma