The FDA will be working over the next few months to ensure tralokinumab is efficient for atopic dermatitis.
At the beginning of July, the US Food and Drug Administration (FDA) accepted LEO Pharma’s Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis.
With the acceptance, the agency will formally review the potential treatment. This means physicians and patients will have a second opportunity to treat the condition, likely by the second quarter of 2021, Kim Kjøller, MD, executive vice president of global research & development at LEO Pharma, said in a recent interview with HCPLive®.
Tralokinumab will be the second biologic for the treatment of atopic dermatitis, he said.
“For all of us that have worked in this field for many years, we also welcome more treatments into the play again because we do realize this is a very heterogeneous disease and we will be needing more opportunities to treat patients moving forward,” he said.
The next steps in the process is for the agency to go through all the data and in the months to come to provide clarifying questions to LEO Pharma about the production of tralokinumab and clinical data. Normally that takes 4-5 months until all the questions are answered. During that time, the FDA will also audit a number of the sites that participated in the clinical studies to make sure everything is safe and in order.