FDA Approves Tralokinumab for Treating Eczema in Adolescents

The FDA has expanded the approval of tralokinumab-ldrm (Adbry) for treating moderate to severe atopic dermatitis in children 12-17 years old. The therapy targets the interleukin (IL)-13 cytokine, a key driver of AD symptoms. Results from the phase 3 ECZTRA 6 trial showed significantly more pediatric patients met primary and key secondary endpoints with tralokinumab-ldrm vs placebo. The safety profile was similar to that seen in adult trials. Amy Paller, MD, who was involved in the trial, stated the importance of having treatment options with demonstrated efficacy in itch reduction and skin clearance. The most common adverse events were upper respiratory tract infections, conjunctivitis, eosinophilia, and injection site reactions.

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