The U.S. Food and Drug Administration has approved Eli Lilly's eczema drug, providing a new treatment option for people with moderate-to-severe atopic dermatitis that does not respond to topical prescriptions.
Atopic dermatitis is a common form of eczema that causes dry, itchy, and scaly patches of skin. It is the most common chronic inflammatory skin disease which affects about 20% of children and 2 to 7% of adults worldwide. The condition is not contagious but often flares up in response to allergens or irritants. Although there is no permanent cure, various treatments can help manage symptoms.
The new injectable drug, Lebrikizumab, branded as Ebglyss, is approved for treating atopic dermatitis in adults and children aged 12 and older who weigh at least 88 pounds. During the clinical trial involving more than 1,000 participants including adults and children, the drug offered "significant skin clearance in patients as early as four weeks and meaningful itch relief as early as two weeks", the company said in a news release. The drug will be available in the market for consumers in the coming weeks.
"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," said Dr. Jonathan Silverberg, the first author of the study that summarized clinical trials in New England Journal of Medicine.
The manufacturer recommends starting the treatment with a strong initial dose of 500 mg, administered as two 250 mg injections at week 0 and week 2. This is followed by 250 mg injections every two weeks until week 16 or until noticeable improvements are achieved. Once the desired clinical response is reached, just a single 250 mg injection every four weeks would be sufficient.
"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the U.S. have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration, and rashes, which can lead to more scratching that may cause the skin to crack and bleed. The approval of EBGLYSS provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms," said Kristin Belleson, President and CEO of the National Eczema Association.
