FDA Approves Lebrikizumab (Ebglyss) for Moderate-to-Severe Atopic Dermatitis
Key Insights
The FDA has approved lebrikizumab (Ebglyss) for treating moderate-to-severe atopic dermatitis (search) in adults and children 12 years and older who weigh at least 88 pounds.
Approval was based on the ADvocate 1, ADvocate 2, and ADhere trials, which showed significant itch relief and skin clearance, sometimes as early as 2-4 weeks.
Lebrikizumab, a monoclonal antibody targeting IL-13 (search), offers an alternative for patients who do not respond well to topical corticosteroids.
The U.S. Food and Drug Administration (FDA) has approved lebrikizumab (Ebglyss; Eli Lilly and Company) for the treatment of moderate-to-severe atopic dermatitis (search) (AD) in adult and pediatric patients 12 years and older, weighing at least 40 kg (88 pounds), whose condition is not adequately controlled with topical prescription therapies. This approval marks a significant advancement in the therapeutic options available for patients with AD, particularly those who require alternatives to topical treatments. The debilitating nature of AD, characterized by relentless itching, inflammation, and dry skin, often necessitates interventions beyond standard topical corticosteroids.
The approval of lebrikizumab was supported by data from three pivotal clinical trials: ADvocate 1, ADvocate 2, and ADhere. These trials evaluated the efficacy and safety of lebrikizumab as a monotherapy or in combination with topical corticosteroids (TCS). ADvocate 1 and ADvocate 2 were 52-week, randomized, double-blind, placebo-controlled, parallel-group, global phase 3 studies designed to assess lebrikizumab as a monotherapy. Averaged data from these studies indicated that 38% of participants achieved clear or almost-clear skin at 16 weeks, compared to 12% in the placebo group. Notably, 10% of participants experienced these results as early as 4 weeks.
ADhere Trial Results
The ADhere trial, a 16-week randomized, double-blind, placebo-controlled, parallel-group, global phase 3 study, evaluated the efficacy and safety of lebrikizumab in combination with TCS in 211 adults and children. Results from the ADhere trial demonstrated that, at week 16, 145 participants (41.2%) achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, compared to 22.1% in the placebo group.
Mechanism of Action and Dosing
Lebrikizumab is a monoclonal antibody that selectively binds to interleukin (IL)-13, a key proinflammatory Th2 cytokine implicated in the pathogenesis of AD. By neutralizing IL-13 (search), lebrikizumab helps to reduce the signs and symptoms of atopic dermatitis (search). The drug is administered as a 250 mg/2 mL injection, with a recommended starting dose of 500 mg (split into two injections) at weeks 0 and 2, followed by 250 mg every two weeks as a maintenance dose until adequate clinical response is achieved. It can be used with or without topical corticosteroids.
Impact on Patients
"Nearly 16.5 million adults in the US have eczema (search), with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration and rashes, which can lead to more scratching that may cause skin to crack and bleed," said Kristin Belleson, president and CEO of the National Eczema Association. "The approval of [lebrikizumab] provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."