The US Food and Drug Administration has approved an every-8-week maintenance dosing regimen for lebrikizumab-lbkz (EBGLYSS) in adults and children aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis. According to Eli Lilly and Company, patients who achieve an adequate clinical response following initial treatment may receive a 250-mg maintenance dose every 8 weeks or every 4 weeks. The company stated that EBGLYSS may be used with or without topical corticosteroids.

The approval was based primarily on longitudinal exposure-response modeling and supported by every-8-week clinical data from an open-label extension of the Phase 3 ADjoin long-term trial, which evaluated lebrikizumab maintenance dosing every 4 weeks and every 8 weeks over 32 weeks in patients with moderate-to-severe atopic dermatitis.

Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University and an author of the ADjoin study, said, “The option to extend EBGLYSS maintenance dosing to every [8] weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis.”

In the 32-week ADjoin every-8-week extension, no new safety signals were identified, according to Eli Lilly and Company, and no patients discontinued treatment because of adverse events through 32 weeks. In the overall EBGLYSS safety profile, the most common adverse reactions were conjunctivitis, injection-site reactions, and herpes zoster.

Lebrikizumab is a monoclonal antibody that selectively targets interleukin-13, a cytokine involved in the pathophysiology of atopic dermatitis. The therapy is approved for use in adults and children aged 12 years and older weighing at least 40 kg whose disease is not adequately controlled with topical prescription therapies or who cannot use topical therapies.

According to Eli Lilly and Company, the Phase 3 clinical development program for lebrikizumab in atopic dermatitis has included more than 1,600 patients across 7 global studies. The recommended starting regimen remains 500 mg at weeks 0 and 2, followed by 250 mg every 2 weeks until week 16 or later when an adequate clinical response is achieved. Patients may then transition to maintenance dosing every 4 weeks or every 8 weeks.

Source: Eli Lilly and Company