FDA approves lebrikizumab for atopic dermatitis in patients 12 years and older

The US Food and Drug Administration (FDA) has approved lebrikizumab (EBGLYSS) for the treatment of patients ≥12 years old with moderate to severe atopic dermatitis who meet weight and disease severity standards warranting potential benefit from the interleukin 13 (IL-13) inhibitor therapy.¹

The indication granted to Eli Lilly and Company on Friday allows for a monthly maintenance 250 mg / 2 mL injection dose of lebrikizumab, used in combination with or without topical corticosteroids, for pediatric, adolescent and adult patients who weight ≥88 lbs and have poorly controlled eczema despite prior topical prescription therapies. The company recommends lebrikizumab be administered at a staring 500 mg dose split across 2 injections at weeks 0 and 2 before shifting to a bi-weekly dose until week 16 or later when adequate clinical response is achieved.

The data supporting lebrikizumab’s indication was based on findings from the ADVocate 1 and 2 trials, as well as the ADhere trial, in which the biologic drug achieved primary outcomes including significant improvement in clear or almost clear skin per Investigators Global Assessment (IGA) scores of 0 or 1 versus placebo (38% vs 12%) among more than 1000 participants. Investigators additionally noted that 1 in 10 patients receiving lebrikizumab achieved IGA 0 or 1 by 4 weeks.

What’s more, three-fourths (77%) of patients who achieved IGA 0 or 1 at week 16 maintained their clear skin at 1 year after switching to once-monthly dosing. Another 48% of patients who achieved IGA 0 or 1 at week 16 who switched from lebrikizumab to placebo maintained their clear skin at 1 year.

In a statement accompanying the approval, Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences, said access to lebrikizumab provides a wide array of patients “a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough."

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies,” Silverberg said. “Many experience poor long-term disease control, and severe itch can significantly impact their daily lives.”

The new indication comes after a previous stall in the pipeline delivery for Eli Lilly, as their application for lebrikizumab for the indicated eczema population previously received a Complete Response Letter (CRL) before resubmission this April.²

References

1. ^{PR Newswire. FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. Press release. Published September 13, 2024. Accessed September 13, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-lillys-ebglyss-lebrikizumab-lbkz-for-adults-and-children-12-years-and-older-with-moderate-to-severe-atopic-dermatitis-302248062.html}
2. ^{Fitch J. BLA resubmitted for lebrikizumab to treat AD patients 12 years and up. Contemporary Pediatrics. Published April 30, 2024. https://www.contemporarypediatrics.com/view/bla-resubmitted-for-lebrikizumab-to-treat-ad-patients-12-years-and-up}