Posted by Michael Wonder on 30 Apr 2021
Update on U.S. FDA review of LEO Pharma’s biologics license application for tralokinumab for the treatment of adults with moderate to severe atopic dermatitis
29 April 2021 - FDA has requested additional data relating to a device component of tralokinumab.
LEO Pharma today announced that the U.S. FDA as part of their review of the company’s biologics license application for tralokinumab, an investigational therapy for adults with moderate to severe atopic dermatitis, has issued a complete response Letter requesting additional data relating to a device component of tralokinumab.
The FDA did not request any new data on the clinical efficacy or safety of the drug product formulation of tralokinumab.
