Tralokinumab BLA for atopic dermatitis accepted by FDA

The FDA has accepted a biologics license application for tralokinumab for the treatment of moderate to severe atopic dermatitis in adults, Leo Pharma announced in a press release.

A fully human monoclonal antibody, tralokinumab neutralizes the interleukin-13 cytokine, which drives inflammation in AD.

“There is a significant unmet medical need for people whose moderate to severe atopic dermatitis remains uncontrolled,” Kim Kjøller, MD, executive vice president, global research and development, Leo Pharma, said in the release. “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.”

Results from the ECZTRA 1, 2 and 3 phase 3 studies, which evaluated the drug’s safety and efficacy, were reviewed for the BLA submission.

A Prescription Drug User Fee Act target action date has been set for the second quarter of 2021.