en.Wedoany.com Reported - Eli Lilly and Company announced that the U.S. Food and Drug Administration has approved a maintenance dosing regimen of EBGLYSS (lebrikizumab-lbkz) as a single injection (250 mg/2 mL) every eight weeks for adult and pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis weighing at least 88 lbs (40 kg), making it the only approved option requiring just six maintenance injections per year.
The drug was previously approved for a monthly maintenance dose. Adrienne Brown, Executive Vice President and President of Lilly Immunology, stated that this new regimen means patients only need to receive treatment six times per year, with no prescription topical medications required during the initial phase. EBGLYSS can now help patients reduce the frequency of flare-ups.
This approval is based on longitudinal exposure-response model data and supported by clinical data from the extension phase of the Phase 3 ADjoin long-term trial (Clinical Trial Registration Number: NCT04392154) evaluating every-8-week dosing. The extension study assessed EBGLYSS maintenance dosing every four weeks or every eight weeks over 32 weeks. Study author Dr. Peter Lio, Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University, noted that this new dosing regimen, which does not mandate topical medications, allows patients to manage their condition according to individual needs.
The recommended initial dosing regimen for EBGLYSS is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or until adequate clinical response is achieved; thereafter, the maintenance dose is 250 mg every four weeks or every eight weeks. In the 32-week ADjoin Q8W extension study, no patients discontinued treatment due to adverse events through Week 32. The most common adverse reactions reported with EBGLYSS (≥1%) were conjunctivitis, injection site reactions, and herpes zoster. Kristin Belleson, President and CEO of the National Eczema Association, stated that patients with moderate-to-severe atopic dermatitis seek treatments that provide durable disease control with fewer injections, and this new option can reduce the daily burden on patients.
Lilly holds exclusive development and commercialization rights for EBGLYSS in the United States, Europe, and other regions worldwide. Almirall has been licensed to develop and commercialize the drug for dermatological indications, including atopic dermatitis.
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