FDA approves tralokinumab for moderate-to-severe atopic dermatitis in pediatric patients

The U.S. Food and Drug Administration has expanded the approval of Adbry (tralokinumab-ldrm) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, according to a press release.

Tralokinumab is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin (IL)-13 cytokine, 1 of the key drivers of AD signs and symptoms.

A loading dose of 300 mg followed by a 150 mg dose every 2 weeks is approved for U.S. pediatric patients aged 12-17 years for tralokinumab, based on Phase 3 ECZTRA 6 trial data. The trial demonstrated tralokinumab’s efficacy in treating moderate-to-severe atopic dermatitis in this age group. Compared to placebo, tralokinumab showed significant improvements, with more patients achieving clear or almost clear skin, substantial disease improvement, and reduced itch.

The safety profile of tralokinumab in pediatric patients was comparable to that observed in adult trials. Common adverse events included upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.

Read the full press release here.