The FDA has given the green light to Eli Lilly and Co.’s Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of moderate-to-severe atopic dermatitis (eczema) in both adults and children 12 years of age and older weighing at least 88 pounds (40 kg). This approval is a significant step forward for patients who struggle with eczema that hasn’t responded well to conventional topical prescription therapies.
Ebglyss operates by directly targeting the inflammatory processes associated with eczema throughout the body. This targeted approach helps to alleviate the uncomfortable symptoms of eczema, including dry, itchy, and irritated skin. The drug comes in a 250 mg/2 mL injection format and can be used with or without topical corticosteroids. The recommended treatment regimen involves a monthly maintenance injection after an initial treatment phase.
The FDA’s approval of Ebglyss is based on robust clinical data gathered from the ADvocate 1, ADvocate 2, and ADhere studies. These studies involved over 1,000 adults and children (aged 12 and older) with moderate-to-severe eczema who were unable to effectively control their symptoms with topical medications. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA 0,1).
The results are impressive. In an average of the two studies (ADvocate 1 and 2), a remarkable 38% of patients who received Ebglyss achieved clear or almost clear skin at 16 weeks, compared to just 12% who received a placebo. Even more encouraging, 10% of patients saw these positive results as early as four weeks. The long-term benefits are also significant. Of those who experienced clear or almost-clear skin at Week 16, a remarkable 77% maintained those results at one year with once-monthly dosing. This sustained improvement highlights Ebglyss’s long-term effectiveness.
Ebglyss also delivered significant itch relief for many patients. On average, 43% of people who took Ebglyss felt itch relief at 16 weeks, compared to 12% who took a placebo. This improvement was observed as early as two weeks for 5% of patients. Of the people who felt itch relief at Week 16, a substantial 85% still felt that relief at one year of treatment with monthly maintenance dosing. This continued itch relief is a significant benefit for patients whose eczema can cause intense discomfort and disrupt their quality of life.
The initial starting dose of Ebglyss is 500 mg (two 250 mg injections) at Week 0 and Week 2. Following the initial phase, the dosage is adjusted to 250 mg every two weeks until Week 16 or later, when adequate clinical response is achieved. Once this point is reached, maintenance dosing shifts to a single monthly injection (250 mg every four weeks).
The approval of Ebglyss offers a new and effective treatment option for patients with moderate-to-severe eczema who are struggling to find relief from their symptoms. This innovative treatment has demonstrated its ability to significantly improve both skin clarity and itch relief, providing hope for a better quality of life for those affected by this chronic condition.
