Eli Lilly has announced that EBGLYSS ™ (lebrikizumab-lbkz) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe atopic dermatitis in adults and children over 12 years.
EBGLYSS 250 mg/2 mL injection is a targeted IL-13 inhibitor that may be used with or without topical corticosteroids. Initial dosing is recommended at 500 mg with two 250 mg injections given at Week 0 and then again at Week 2. This is then to be followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved. After this, it is given as a single monthly maintenance injection.
EBGLYSS is recommended for patients over 12 years who weigh at least 88 pounds and who have moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription therapies.
According to Jonathan I. Silverberg, M.D., Ph.D., M.P.H., professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, and first author of the New England Journal of Medicine manuscript summarizing EBGLYSS clinical trials, “Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives. Today’s FDA approval of EBGLYSS is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough.”
The approval of EBGLYSS has come after results from the ADvocate 1, ADvocate 2, and ADhere studies which included over 1,000 adults and children. The subjects all had moderate-to-severe eczema who were unable to control their symptoms with topical prescription medications.
Results revealed that an average of 38% of patients who took EBGLYSS achieved clear or almost-clear skin at 16 weeks, compared to only 12% with placebo. In addition, 10% saw these same results at only four weeks. Furthermore, of those who experienced clear or almost-clear skin at Week 16, a total of 77% were able to maintain these results after one year with monthly dosing. The study also reported that 48% of patients who were switched from EBGLYSS to placebo at Week 16 maintained their results at one year.
Concerning itch relief, approximately 43% of those who took EBGLYSS felt itch relief at Week 16 compared to 12% on placebo. Additionally, 5% of those EBGLYSS-treated patients felt itch relief as early as two weeks. For those experiencing itch relief at Week 16, 85% still felt that relief at one year with once monthly dosing. Furthermore, 66% of those who were switched from EBGLYSS to placebo maintained this itch relief at one year.
Common side effects reported with EBGLYSS include eye and eyelid inflammation, such as redness, swelling and itching; injection site reactions and shingles.
"People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives. Today's approval allows people the opportunity to reimagine life with eczema as EBGLYSS offers a targeted approach to reduce a main cause of eczema inflammation. EBGLYSS provides long-lasting symptom relief with a convenient once-monthly maintenance dose."
Eli Lilly reports that EBGLYSS will be available in the United States in the coming weeks.
