EMA validates LEO's tralokinumab submission

The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) under development by privately-held Danish dermatology specialist LEO Pharma.

The acceptance of this MAA marks the beginning of the formal review procedure for this potential new treatment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

Tralokinumab is a fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine which is a key driver of the underlying inflammation in AD. The MAA is based on data from the pivotal ECZTRA 1, 2 and 3 Phase III studies evaluating the efficacy and safety of tralokinumab. The efficacy and safety of tralokinumab have not been evaluated by any regulatory authority.