FDA Approves Lebrikizumab for Atopic Dermatitis

The US Food and Drug Administration (FDA) has approved the targeted interleukin (IL)-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate-to-severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

Candidates for the injectable drug must weigh at least 88 pounds (40 kg); the recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks).

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate-to-severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.