Lebrikizumab Gains FDA Approval for AD

The targeted IL-13 inhibitor lebrikizumab was approved by the US Food and Drug Administration for the treatment of adults and children 12 and older who weigh at least 88 lbs with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription therapies, Eli Lilly and Company announced.

Eli Lilly’s EBGLYSS 250 mg/2 mL lebrikizumab injection can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following the initial phase of treatment. The recommended initial starting dose of EBGLYSS is 500 mg (two 250-mg injections) at Week 0 and Week 2, followed by 250 mg every 1 weeks until Week 16 or later when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every four weeks).

"Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and first author of the New England Journal of Medicine manuscript summarizing EBGLYSS clinical trials. "Today's FDA approval of EBGLYSS 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 was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included more than 1,000 adults and children (12 and older) with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medicines.