FDA Approves Ebglyss (Lebrikizumab-lbkz) for Moderate-to-Severe Atopic Dermatitis in Adults and Children 12 Years and Older

FDA Approval:
The FDA has approved Eli Lilly and Company’s Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds (40 kg) and whose condition is not well controlled with topical prescription therapies.

Treatment Mechanism:
Ebglyss is a targeted IL-13 inhibitor that works by reducing inflammation throughout the body, which can help alleviate the dry, itchy, and irritated skin associated with atopic dermatitis.

Dosage:
The recommended starting dose is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg injections 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).

Clinical Trials: The approval was based on data from three clinical trials:
ADvocate 1, ADvocate 2, and ADhere, which involved over 1,000 adults and children aged 12 years and older with moderate-to-severe eczema that did not improve with topical prescription treatments.

Availability:
Ebglyss will be available in the US in the coming weeks, with Lilly offering a patient support program including co-pay assistance for eligible, commercially insured patients.

Previous Approvals:
Ebglyss was previously approved in Europe in 2023 and in Japan in January 2024, with additional markets expected later this year.