The FDA has accepted the Biologics License Application (BLA) for Leo Pharma’s tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD), the company says. A taget action date has been set in the second quarter of 2021.

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 BLA submission is based on data from the pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating the safety and efficacy of tralokinumab.

“There is a significant unmet medical need for people whose moderate-to-severe atopic dermatitis remains uncontrolled,” said Kim Kjøller, MD, Executive Vice President, Global Research and Development, LEO Pharma. “If approved, tralokinumab could become the first biologic available to specifically neutralize the IL-13 cytokine and, most importantly, offer a more targeted approach for adults living with this debilitating disease. We will continue to work closely with the FDA as they review this application.”

The European Medicines Agency (EMA) recently accepted the marketing authorization application (MAA) for tralokinumab and regulatory review is underway by the Committee for Medicinal Products for Human Use (CHMP).