By VETTAPHARMA reporter – Derek Roche: The U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing regimen for EBGLYSS (lebrikizumab-lbkz), allowing adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis to receive a single 250 mg injection every eight weeks following achievement of an adequate clinical response.
The approval makes EBGLYSS the only approved treatment in its class offering as few as six maintenance injections annually without requiring prescription topical therapies from the start.
The approval expands upon EBGLYSS’ existing once-monthly maintenance regimen and is supported by longitudinal exposure-response modeling and clinical data from the Phase 3 ADjoin extension study (NCT04392154). The extension evaluated maintenance dosing every four weeks and every eight weeks over 32 weeks in patients with moderate-to-severe atopic dermatitis.
According to Eli Lilly, no new safety signals were observed during the 32-week ADjoin every-eight-week extension. No patients discontinued treatment because of adverse events during the extension period. The most frequently reported adverse reactions were conjunctivitis, injection-site reactions, and herpes zoster.
EBGLYSS is a monoclonal antibody that selectively targets interleukin-13 (IL-13), a key cytokine implicated in the pathophysiology of atopic dermatitis. The therapy has been evaluated across a comprehensive Phase 3 development program involving more than 1,600 patients, including the ADvocate 1 and 2, ADhere, ADjoin, ADore, ADopt-VA, ADmirable, and ADapt studies.
The approved maintenance schedule follows an induction period of 250 mg every two weeks for at least 16 weeks or until adequate clinical response is achieved, after which patients may receive maintenance dosing every four weeks or every eight weeks. Lilly stated that the new option is intended to reduce treatment burden while maintaining durable disease control for patients living with moderate-to-severe atopic dermatitis.
Quick FAQs
1. What Is EBGLYSS?
EBGLYSS (lebrikizumab-lbkz) is a monoclonal antibody that selectively targets and neutralizes IL-13, a cytokine that plays a central role in the inflammatory processes underlying atopic dermatitis.
2. What Did The FDA Approve?
The FDA approved a maintenance regimen of one 250 mg EBGLYSS injection every eight weeks for adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis after achieving an adequate clinical response.
3. What Is The ADjoin Study?
ADjoin (NCT04392154) is a long-term Phase 3 extension study evaluating the safety and efficacy of EBGLYSS maintenance dosing every four weeks and every eight weeks over a 32-week period in patients with moderate-to-severe atopic dermatitis.
4. What Is Atopic Dermatitis?
Atopic dermatitis is a chronic inflammatory skin disease characterized by eczema, itching, and recurrent flares that can significantly affect quality of life and daily functioning.
5. What Were The Key Results?
The FDA approval was supported by exposure-response modeling and Phase 3 ADjoin extension data. No new safety signals were identified, and no patients discontinued treatment due to adverse events during the 32-week extension.
6. Why Is This Important?
The approval provides patients with a maintenance option requiring as few as six injections per year while maintaining access to a biologic treatment that does not require prescription topical therapies from the start, potentially reducing long-term treatment burden.
