EBGLYSS is now the only approved option that offers as few as six maintenance injections per year with no required topicals from the start

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS (lebrikizumab-lbkz) for subcutaneous use in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis. EBGLYSS is already approved for a once-monthly maintenance dose, with long-term data showing durable disease control. Now, EBGLYSS gives patients with moderate-to-severe atopic dermatitis the option to manage their condition with as few as six maintenance injections per year.¹

"Today's approval builds on EBGLYSS' established long-term durability, with a new option for one maintenance dose every eight weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as six times a year—without prescription topicals from the start," said Adrienne Brown, executive vice president and president of Lilly Immunology. "EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis."

The approval is based on longitudinal exposure-response modeling data and supported by every-eight-week clinical data from an extension to the Phase 3 ADjoin long-term trial, which evaluated EBGLYSS maintenance dosing every four weeks or every eight weeks over 32 weeks.²

"The option to extend EBGLYSS maintenance dosing to every eight weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis," said Peter Lio, M.D., author of the ADjoin study and clinical assistant professor of dermatology and pediatrics, Northwestern University. "This new dosing regimen without mandatory topicals gives patients a new option to manage their condition based on individual needs. It's about meeting patients where they are in their lives."

No new safety signals were noted in the EBGLYSS safety data in the 32-week ADjoin Q8W extension. No patients discontinued due to adverse events through 32 weeks. The most common (≥1%) adverse reactions reported with EBGLYSS are conjunctivitis, injection site reactions and herpes zoster.¹

"Living with moderate-to-severe atopic dermatitis often means dealing with a cycle of symptoms and time-intensive treatment routines during and in-between flares," said Kristin Belleson, president and CEO of the National Eczema Association. "Patients living with moderate-to-severe atopic dermatitis seek treatments that can offer durable disease control and fewer injections. This new option can ease the burden, allowing patients to spend less time thinking about managing their condition on a daily basis."

Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe.