FDA Approves Lilly’s Ebglyss for Moderate-to-Severe Atopic Dermatitis

FDA Approval:
The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 12 years and older who weigh at least 40 kg.

Treatment Mechanism:
Ebglyss is a monoclonal antibody that selectively targets and neutralizes IL-13, a primary cytokine implicated in the pathophysiology of eczema, thereby disrupting the type 2 inflammation cascade in the skin.

Clinical Trials:
The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and children with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medicines.

Efficacy:
Patients treated with Ebglyss experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks, with long-lasting efficacy maintained through one year of treatment with a monthly maintenance dose.

Availability:
Ebglyss will be available in the U.S. in the coming weeks, with Lilly working with insurers and health providers to ensure patient access to the treatment.

Previous Rejection:
The FDA had previously rejected Ebglyss in October 2023 due to manufacturing concerns, which have since been addressed.