Eli Lilly’s eczema drug gets FDA approval, injectable treatment will be available within weeks

The U.S. Food and Drug Administration has approved an eczema drug from Eli Lilly, providing a novel treatment option for people with moderate to severe atopic dermatitis that doesn’t respond to prescription topical medications.

Atopic dermatitis is a common form eczema which causes droughty, itchy, scaly patches of skin. It is the most common chronic inflammatory skin disease, affecting 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 enduring cure, various treatments can lend a hand control symptoms.

The novel injectable drug, Lebrikizumab, sold under the brand name Ebglyss, is approved to treat atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds. In a clinical trial involving more than 1,000 participants, including adults and children, the drug offered “significant skin clearing in patients in as little as four weeks and significant itch relief in as little as two weeks,” the company reported in press releaseThe drug will be available on the market to consumers in the coming weeks.

“Patients continue to struggle to control moderate to severe atopic dermatitis with currently available therapies. Many experience impoverished disease control in the long term, and severe itching can significantly impact their daily lives. Today’s FDA approval of Ebglyss is a major win for patients because we now have a novel first-line biologic treatment option for moderate to severe disease when topical prescriptions are not sufficient,” said Jonathan Silverberg, MD, first author of the study summarizing the clinical trials in the Recent England Journal of Medicine.

The manufacturer recommends starting treatment with a powerful initial dose of 500 mg, given 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 improvement is achieved. Once the desired clinical response is achieved, one 250 mg injection every four weeks is sufficient.

“Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the U.S. have eczema, and 6.6 million experience moderate to severe symptoms, including itching, droughty and flaky skin, discoloration and rashes that can lead to more scratching, which can cause the skin to crack and bleed. The approval of EBGLYSS offers hope and promise to the eczema community and those still seeking lasting relief from their troublesome symptoms,” said Kristin Belleson, president and CEO of the National Eczema Association.