The U.S. Food and Drug Administration (FDA) has approved Eli Lilly's EBGLYSS™ (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis, commonly known as eczema. The drug is now available for adults and children aged 12 and older who have not achieved adequate control with topical treatments.
EBGLYSS, a biologic therapy targeting inflammation caused by the skin condition, provides a new treatment option for patients suffering from severe eczema. Clinical trials showed significant improvement in skin clearance as early as four weeks, with relief from itching beginning in two weeks. The drug is administered via injection and offers long-lasting efficacy, with a monthly maintenance dose required after the initial treatment phase.
The FDA's approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which involved over 1,000 patients. In these trials, 38% of patients achieved clear or nearly clear skin at 16 weeks, and 43% experienced itch relief. Most patients maintained their improvements for up to a year with continued monthly dosing.
Dr. Jonathan Silverberg, a dermatologist at George Washington University, emphasized the importance of the approval, noting that many patients struggle with long-term disease control. "EBGLYSS is a big win for patients," he said, "providing a new first-line biologic option for those with moderate-to-severe eczema."
EBGLYSS is expected to become available in the U.S. in the coming weeks. Lilly is working to ensure broad access through its patient support program, including co-pay assistance for eligible individuals.
Eli Lilly holds exclusive rights to market EBGLYSS in the U.S. and other global markets, while its partner, Almirall S.A., handles its distribution in Europe.
