The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). This approval marks a significant advancement in the treatment landscape for atopic dermatitis, offering a new targeted therapy for patients whose condition is not adequately controlled with topical prescription medications.
Clinical Efficacy and Trial Data
The FDA's decision was based on data from three pivotal Phase 3 trials: ADvocate 1, ADvocate 2, and ADhere, involving over 1,000 patients with moderate-to-severe eczema. These studies evaluated the efficacy and safety of Ebglyss as a monotherapy and in combination with topical corticosteroids.
Pooled data from ADvocate 1 and ADvocate 2 showed that 38% of patients treated with Ebglyss achieved clear or almost-clear skin (Investigator Global Assessment [IGA] score of 0 or 1) at 16 weeks, compared to 12% of placebo recipients. Furthermore, 77% of those achieving an IGA score of 0-1 at 16 weeks maintained that level of response at 1 year with monthly maintenance therapy, compared with 48% of responders who stopped therapy.
In terms of itch relief, 43% of patients in the Ebglyss groups reported a reduction of at least 4 points on an 11-point pruritus numerical rating scale (NRS) at week 16, compared to 12% in the placebo groups. The majority of responders maintained itch relief out to a year with maintenance dosing: 85% versus 66% for those who stopped treatment after 16 weeks.
Dosing and Administration
Ebglyss is administered as a subcutaneous injection. The recommended initial dose is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two 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). Ebglyss can be used with or without topical corticosteroids.
Safety Profile
The most common adverse reactions reported with Ebglyss were conjunctivitis, injection site reactions, and herpes zoster. Warnings and precautions in the labeling include hypersensitivity reactions, conjunctivitis and keratitis, parasitic infections, and the need to complete all age-appropriate vaccinations prior to initiating treatment.
Expert Commentary
"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, of George Washington University School of Medicine and Health Sciences. "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."
Market Landscape
The approval of Ebglyss intensifies competition in the atopic dermatitis market, joining existing biologics such as Dupixent (dupilumab) and Adbry/Adtralza (tralokinumab). While these therapies share similar mechanisms of action, comparative studies suggest that lebrikizumab may offer advantages in binding affinity and dosing frequency. Ebglyss is expected to capture market share by offering a less frequent dosing schedule, with a maintenance dose of 250mg administered subcutaneously every 4 weeks, compared to the bi-weekly regimens of its competitors.
Availability and Support
Lilly anticipates Ebglyss will be available in the U.S. in the coming weeks. The company is committed to ensuring patient access through collaborations with insurers and health systems, and will offer patient support programs, including co-pay assistance for eligible, commercially insured patients.
Long-Term Efficacy
Data from the ADjoin long-term extension study demonstrated that Ebglyss provided sustained disease control for up to three years in over 80% of subjects with moderate-to-severe atopic dermatitis. These results underscore the potential for Ebglyss to provide durable symptom relief and improve the long-term management of atopic dermatitis.
