FDA Approves Lebrikizumab (Ebglyss) for Moderate-to-Severe Atopic Dermatitis in Patients 12 and Older
Key Insights
The FDA has approved lebrikizumab (Ebglyss), an interleukin-13 (search) inhibitor, for treating moderate-to-severe atopic dermatitis (search) in patients aged 12 and older.
Clinical trials (ADvocate 1, ADvocate 2, and ADhere) demonstrated that lebrikizumab, alone or with topical corticosteroids, significantly improved skin clearance compared to placebo.
Lebrikizumab offers a convenient monthly maintenance dose and provides lasting symptom relief for those whose eczema (search) is not well-controlled with topical therapies.
The FDA has granted approval to lebrikizumab (Ebglyss; Eli Lilly) for the treatment of moderate-to-severe atopic dermatitis (search) (AD) in patients aged 12 years and older, weighing at least 88 pounds, whose condition is not adequately controlled with topical treatments. This approval marks a new first-line biologic option for these patients, offering a targeted approach to reduce eczema (search) inflammation.
Mechanism of Action
Lebrikizumab functions as an interleukin (IL)-13 inhibitor, which prevents the skin from becoming spongiotic, thereby alleviating itching associated with atopic dermatitis (search). The drug is administered via a 250 mg/2 mL injection and can be used with or without topical corticosteroids (TCS).
The recommended initial dose is 500 mg (two 250-mg injections) at weeks 0 and 2, followed by 250 mg every two weeks until week 16 or until adequate clinical response is achieved. Maintenance dosing involves a single monthly 250 mg injection every four weeks.
Clinical Trial Data
The approval was based on data from the ADvocate 1, ADvocate 2, and ADhere studies, which collectively involved over 1000 adults and children with moderate-to-severe AD. The primary endpoint for each study was clear (Investigator Global Assessment [IGA], 0) or almost clear (IGA, 1) skin at week 16 of treatment.
In the ADvocate 1 and 2 studies, patients received lebrikizumab 500 mg initially and at week 2, followed by 250 mg or placebo every two weeks during the 16-week treatment period. An average of 38% of patients receiving lebrikizumab achieved clear or almost clear skin at week 16, compared to 12% with placebo. Notably, 10% of patients saw these results as early as 4 weeks. Among those who achieved clinical response, 77% maintained clear or almost clear skin at 1 year with once-monthly dosing, while only 48% of patients who switched to placebo at week 16 maintained these results.
The ADhere study, a 16-week phase 3 trial, evaluated the efficacy and safety of lebrikizumab in combination with TCS in 211 adults and children with moderate-to-severe AD inadequately controlled by topical medications. Results showed that 41.2% of patients receiving lebrikizumab plus TCS achieved clear or almost clear skin at week 16, compared to 22.1% receiving placebo plus TCS.
Impact and Availability
Eli Lilly is preparing to launch lebrikizumab in the US in the coming weeks and is collaborating with insurers, health systems, and providers to ensure broad patient access. The drug has already been approved by the European Commission in 2023 and Japan in January 2024, with expectations for further approvals in additional markets later this year.
According to Kristin Belleson, president and CEO of the National Eczema (search) Association, nearly 16.5 million adults in the US have eczema, with 6.6 million experiencing moderate-to-severe symptoms. The approval of Ebglyss offers renewed hope for the eczema community seeking lasting relief from disruptive symptoms, as stated in a press release.