Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) approved EBGLYSS (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

"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," said Jonathan Silverberg, MD, PhD, MPH., 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.

"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," Silverberg added.

The approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and children (aged 12 and older) with moderate-to-severe eczema who were unable to control their symptoms with topical prescription medicines. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA 0,1).

In an average of two studies (ADvocate 1 and 2), 38 percent of people who took EBGLYSS achieved clear or almost-clear skin at 16 weeks (versus 12 percent with placebo) and 10 percent saw these results as early as four weeks.

Of the people who experienced clear or almost-clear skin at Week 16, 77 percent maintained those results at one year with once-monthly dosing. Forty-eight percent of responders who were switched from EBGLYSS to placebo at Week 16 maintained these results at one year.

Similarly, in both studies, many people experienced itch relief with EBGLYSS. On average, 43 percent of people who took EBGLYSS felt itch relief at 16 weeks (compared to 12 percent who took placebo) and five percent felt relief as early as two weeks.

Of the people who felt itch relief at Week 16, 85 percent still felt that relief at one year of treatment with monthly maintenance dosing. Sixty-six percent of responders who were switched from EBGLYSS to placebo at Week 16 maintained these results at one year.

"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US 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 skin to crack and bleed," said Kristin Belleson, President and CEO of the National Eczema Association.

"The approval of EBGLYSS provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms," added Belleson.

The most common side effects of EBGLYSS include eye and eyelid inflammation, such as redness, swelling and itching; injection site reactions and shingles (herpes zoster). EBGLYSS cannot be used in people allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. The maintenance period was generally consistent with the 16-week safety profile throughout multiple studies. 

"People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives," said Daniel Skovronsky, MD, PhD, Chief Scientific Officer and President of Lilly Research Laboratories, and President, Lilly Immunology.

"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," added Skovronsky.