The US Food and Drug Administration (FDA) today announced it has expanded the approval of tralokinumab-ldrm (Adbry) for treating moderate to severe atopic dermatitis (AD) in children 12-17 years old, according to a press release from the manufacturer, Leo Pharma.
The therapy is for those whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advised.
It is the first treatment for pediatric patients with moderate to severe AD that specifically targets the interleukin (IL)-13 cytokine, one of the key drivers of AD symptoms. Tralokinumab was first approved by the FDA in December 2021 for the same indication in adults.
"It's so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance," Amy Paller, MD, chair of the department of dermatology, Northwestern University, Chicago, said in the manufacturer's release.
Paller is the international coordinating investigator for the phase 3 ECZTRA 6 trial, the results of which informed the FDA's decision. Significantly more pediatric patients in the randomized, double-blind, placebo-controlled, parallel-group, multinational 52-week trial met the primary and key secondary endpoints of Investigator's Global Assessment (IGA) 0/1, Eczema Area and Severity Index (EASI)-75, and itch at Week 16 with tralokinumab-ldrm vs placebo.
ECZTRA 6 included 289 patients aged 12-17 years (195 tralokinumab-ldrm patients and 94 placebo patients), and evaluated the efficacy and safety compared with placebo in pediatric patients with moderate to severe atopic dermatitis who were candidates for systemic therapy.
Results of the trial, according to the company, included:
The safety profile was similar to that seen in the ECZTRA 1, 2, and 3 adult trials, according to the press release. The most common adverse events (with an incidence of at least 1%) were upper respiratory tract infections (mainly reported as a common cold); conjunctivitis; eosinophilia; and injection site reactions.
Paller is an ECZTRA 6 clinical trial investigator and a paid consultant of LEO Pharma.
Comments