FDA Approves Lebrikizumab Treatment of Eczema Among Patients Aged 12 and Older

The US Food and Drug Administration (FDA) approved lebrikizumab-lbkz (EBGLYSS) for the treatment of adults and children aged 12 years or older with moderate-to-severe atopic dermatitis that has not been adequately controlled using topicals.¹

Lebrikizumab is a targeted IL-13 inhibitor and its approval specifically relates to patients in the aforementioned age range who weigh at least 88 pounds (40 kg). This treatment targets the inflammation which is present beneath the skin and contributes to the dryness, pruritus, and irritation caused by eczema.

“Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a statement. “Today's FDA approval of (lebrikizumab) is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough.”

The approval by the FDA followed the positive findings of the ADvocate 1, ADvocate 2, and ADhere clinical studies. ADvocate 1 and 2 were 52-week, phase 3 global studies assessing lebrikizumab as monotherapy, and the ADhere study tested the drug in combination with topical corticosteroids over the course of a 16-week period.²

Altogether, these trials involved a total of 1000 participants, the primary goal being evaluating skin clearance by the 16-week mark, using a measure of clear or nearly clear skin on the Investigator Global Assessment (IGA). About 38 percent of subjects treated with the drug were successful in achieving this outcome, versus 12 percent in the placebo arm.¹

Among the participants who had improvement at the 16-week mark, 77 percent were able to maintain their results for up to a year with monthly injections. Relief from itch was also noted by investigators in these trials, as 43 percent of subjects reported relief by the 16-week mark, versus 12 percent in the placebo arm.

The announcement by Lilly noted that common side effects of lebikizumab included reactions at injection sites, inflammation on the eye and eyelid, and shingles. The researchers of the aforementioned trials noted that the safety profile at Week 16 showed consistency in the maintenance phase of their research.

Lebrikizumab is anticipated to be available in the US in upcoming weeks, and has already been approved by the European Commission in 2023 and in Japan by January 2024. The drug’s safety and efficacy were noted as not established among children under 12 years.

It is available as a 250 mg/2 mL injection, and can be administered either with or without use of topical corticosteroids. Initial treatment involves a starting dose of 500 mg once in the first 2 weeks, followed by 250 mg injections on an every-2-week course until the 16-week mark. A maintenance regimen of a single monthly injection is used after clinical response.

References

1. ^{FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. September 13, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and. Date accessed: September 13, 2024.}
2. ^{Smith T. Lebrikizumab for Atopic Dermatitis Resubmitted for FDA Approval After Previous Rejection. HCPLive. April 30, 2024. https://www.hcplive.com/view/lebrikizumab-for-atopic-dermatitis-resubmitted-for-fda-approval-after-previous-rejection. Date accessed: September 13, 2024.}