FDA Approves Tralokinumab-ldrm for Atopic Dermatitis in Patients Ages 12-17

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LEO Pharma Inc. has announced today the expansion of the approval of Adbry (tralokinumab-ldrm) by the US Food and Drug Administration (FDA) to include pediatric patients aged 12-17 years with moderate-to-severe atopic dermatitis (AD). Adbry is now recognized as the first and only FDA-approved biologic designed to specifically bind to and inhibit the interleukin (IL)-13 cytokine.

This expansion encompasses those whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The FDA approved dosing for pediatric patients is an initial loading dose of 300 mg, followed by a 150 mg dose every 2 weeks.

This decision stems from the positive results from the phase 3 ECZTRA 6 trial, involving 289 pediatric patients aged 12-17 with moderate-to-severe AD.

In the trial, 98 patients received an initial dose of Adbry 300 mg followed by 150 mg every other week up to week 16. The trial successfully met its primary and key secondary endpoints, revealing substantial improvements with Adbry compared to a placebo:

1. Clear or almost clear skin: Adbry outperformed placebo, with 21% of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1, in contrast to 4% with placebo.
2. Disease improvement: Adbry demonstrated significant disease improvement, with 29% of patients achieving at least a 75% improvement in their Eczema Area and Severity Index score (EASI-75), compared to 6% with placebo.
3. Reduced itch: Adbry significantly reduced itch, with 23% of patients achieving at least a 4-point reduction in Adolescent Worst Pruritis Numerical Rating Scale (NRS), while only 3% experienced this reduction with placebo.
4. EASI-90 Improvement: A higher proportion of pediatric patients receiving Adbry achieved at least a 90% improvement in their Eczema Area and Severity Index score (EASI-90) compared to those receiving placebo.

The safety profile of Adbry, evaluated over 16 weeks and 52 weeks, was comparable to trials in adults with atopic dermatitis.

Amy Paller, MD, chair of the Department of Dermatology in the Feinberg School of Medicine at Northwestern University, highlighted the importance of having treatment options with demonstrated efficacy in itch reduction and skin clearance for pediatric patients.

“We know the symptoms associated with moderate-to-severe atopic dermatitis can have an impact on pediatric patients, which is why it’s so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance. Clinical trial results that provide this evidence are invaluable to clinicians evaluating the safety and efficacy of treatment options for their pediatric patients,” Paller said in a press release.

In a statement for Dermatology Times, Christopher Bunick, MD, PhD, associate professor of dermatology and physician-scientist at the Yale School of Medicine in New Haven, Connecticut, expressed excitement at the news.

“It is really exciting that for our pediatric patients ages 12 to 17 we now have tralokinumab approved for use to treat moderate to severe atopic dermatitis. There are a large number of pediatric patients in need of a targeted biologic therapy for AD, and the FDA approval of tralokinumab expands the options available to dermatologists to help this group of pediatric atopic dermatitis patients. Importantly, at a time when our understanding of the molecular heterogeneity of AD and its pathogenic cytokines are evolving, tralokinumab’s success in Ecztra 6 underscores the role of IL-13 as a major driver of adolescent atopic dermatitis and itch," Bunick said. "Adolescents enrolled in Ecztra 6 generally had a high burden of AD, often with comorbid atopic disease like asthma, rhinitis and food allergies, emphasizing the effectiveness and safety of tralokinumb and IL-13 cytokine inhibition in treating atopic dermatitis patients. US dermatologists should be aware tralokinumab was approved for 300 mg loading dose following by 150 mg every 2 weeks thereafter; this is in contrast to Canada and Europe where it is 300 mg every 2 weeks in the adolescent population. Overall, a major win for adolescents with AD and their parents.”

Reference

Leo Pharma Inc.. announces U.S. FDA approval of Adbry (tralokinumab-LDRM) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. Business Wire. December 15, 2023. Accessed December 15, 2023. https://www.businesswire.com/news/home/20231215374551/en/LEO-Pharma-Inc.-Announces-U.S.-FDA-approval-of-Adbry%C2%AE-tralokinumab-ldrm-for-the-Treatment-of-Moderate-to-severe-Atopic-Dermatitis-in-Pediatric-Patients-Aged-12-17-Years