Posted by Michael Wonder on 10 Jul 2020
Leo Pharma announces U.S. FDA acceptance of biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
9 July 2020 - Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and efficacy of tralokinumab.
Leo Pharma today announced that the biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis has been accepted for review by the U.S. FDA.
The acceptance of the application 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.
