Managing chronic eczema may soon be easier than you thought.

 

The US Food and Drug Administration has approved a new, extended maintenance schedule for Eli Lilly’s EBGLYSS (lebrikizumab-lbkz), allowing patients with moderate-to-severe atopic dermatitis to receive just one injection every eight weeks.

 

The move makes EBGLYSS the only therapy offering as few as six maintenance injections per year, with no required topical treatments from the start, according to the company.

 

“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, president of Lilly Immunology. 

 

“EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis.”

 

The FDA decision applies to adults and children aged 12 and older weighing at least 88 pounds (40 kg). EBGLYSS is already approved as a once-monthly maintenance therapy, but the new data-backed option extends dosing intervals further.

 

The approval is based on exposure-response modeling and results from the Phase 3 ADjoin extension study, which evaluated both four-week and eight-week dosing over 32 weeks.

 

“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, author of the ADjoin study and clinical assistant professor of dermatology and pediatrics at 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.”

 

Safety data from the 32-week extension showed no new safety signals, and no patients discontinued treatment due to adverse events. The most common side effects included conjunctivitis, injection site reactions, and herpes zoster.

 

“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.”

 

EBGLYSS, a monoclonal antibody targeting IL-13, is already approved in multiple regions, including the US, EU, Japan, and Canada. Lilly holds global rights outside Europe, where Almirall has licensing for dermatology indications.