Leo Pharma files at FDA a BLA for tralokinumab to treat moderate-to-severe atopic dermatitis.

LEO Pharma A/S, a global leader in medical dermatology, announced that the Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been accepted for review by the FDA. The acceptance of the BLA is the beginning of the formal review procedure for this potential new treatment by the FDA. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date in the second quarter of 2021.

A regulatory review in Europe is already underway, with an application accepted on 12 June.The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab.