FDA Approves Lilly's EBGLYSS™ for Moderate-to-Severe Atopic Dermatitis in Individuals 12+

EBGLYSS offers a new first-line biologic treatment option for individuals with moderate-to-severe atopic dermatitis that is not adequately managed by topical therapies. According to Eli Lilly and Company, the U.S. Food and Drug Administration (FDA) has approved EBGLYSS™ (lebrikizumab-lbkz), targeting the IL-13 pathway to treat both adults and children aged 12 and older who weigh at least 88 pounds. This approval represents a significant advancement in the treatment options available for patients struggling with the debilitating symptoms of eczema.

EBGLYSS is administered as a 250 mg/2 mL injection and can be used in conjunction with or without topical corticosteroids. The dosing regimen begins with an initial dose of 500 mg at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16. Once an adequate clinical response is achieved, a maintenance dose of 250 mg every four weeks is recommended. This treatment has shown to provide long-lasting efficacy, with patients maintaining symptom relief through one year of monthly maintenance dosing.

A notable aspect of EBGLYSS is its rapid onset of action. Patients have reported significant skin clearance as early as four weeks into the treatment, and meaningful itch relief has been observed within just two weeks. Clinical trials have demonstrated that 38% of patients achieved clear or almost clear skin by Week 16, compared to 12% receiving a placebo. Furthermore, 77% of those who experienced clear skin at Week 16 maintained their results at the one-year mark with once-monthly dosing. For itch relief, 43% of patients reported improvement at 16 weeks, with 85% maintaining relief at one year.

The FDA's approval was based on the results from the ADvocate 1, ADvocate 2, and ADhere studies, which involved over 1,000 participants with moderate-to-severe eczema unresponsive to topical treatments. The primary endpoint of these studies was the achievement of clear or almost clear skin at 16 weeks, evaluated by the Investigator Global Assessment (IGA). Secondary endpoints included measures such as the Eczema Area and Severity Index (EASI) and Pruritus Numeric Rating Scale, which assess the extent and severity of the disease and the intensity of itch, respectively.

For many patients, controlling moderate-to-severe atopic dermatitis remains a challenge despite the availability of various therapies. Dr. Jonathan Silverberg, a professor of dermatology at George Washington University, emphasized the significance of EBGLYSS as a new treatment option that offers hope for better disease management. Kristin Belleson, President and CEO of the National Eczema Association, echoed this sentiment, highlighting the potential for EBGLYSS to provide lasting relief from the disruptive symptoms of eczema.

EBGLYSS has undergone extensive evaluation in clinical trials, showing a consistent safety profile. Common side effects include eye and eyelid inflammation, injection site reactions, and shingles. Patients with allergies to lebrikizumab-lbkz or any ingredients in EBGLYSS should not use the medication. Additionally, precautions should be taken for patients with parasitic infections or those scheduled to receive live vaccines.

Eli Lilly and Company, in collaboration with Almirall S.A., holds exclusive rights for the development and commercialization of EBGLYSS worldwide, except in Europe, where Almirall S.A. is licensed to develop and market the treatment for dermatological conditions. The company aims to ensure patient access to EBGLYSS through support programs and partnerships with healthcare providers and insurers.

EBGLYSS represents a promising advancement in the management of moderate-to-severe atopic dermatitis, offering patients a new avenue for achieving long-term relief from their symptoms. As it becomes available in the United States, patients and healthcare providers now have an additional tool to combat the challenges posed by this chronic skin condition.