Lilly wins new FDA approval for eczema drug Ebglyss

The FDA has broadened the label for Eli Lilly's anti-IL-13 antibody Ebglyss, approving a maintenance regimen for atopic dermatitis (eczema) that involves just six injections a year.

After a period of induction therapy with subcutaneous injections every two weeks, Ebglyss (lebrikizumab) can now be given every eight weeks, rather than every four weeks, which could give it a competitive edge over current IL-13-targeting drugs, namely Sanofi/Regeneron's Dupixent (dupilumab) and LEO Pharma's Adbry/Adtralza (tralokinumab), which are dosed every two or four weeks depending on patient characteristics.

According to Clarivate, that dosing advantage – along with more selective IL-13 inhibition and strong efficacy and safety data – could translate into a $6 billion peak sales opportunity for Lilly and Almirall, which has licensed rights to the drug in Europe from Dermira. Lilly claimed its rights to the treatment in 2020 when it spent $1.1 billion to acquire Dermira.

Lilly has also emphasised that patients treated with Ebglyss do not need to take topical therapies such as emollients, corticosteroids, or calcineurin inhibitors, which are sometimes recommended but not mandatory with the other IL-13-acting drugs.

"Today's approval builds on Ebglyss' established long-term durability, with a new option for one maintenance dose every eight weeks," said Adrienne Brown, president of Lilly Immunology.

"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," she added. "Ebglyss now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis."

The approval is based on the Q8W Adjoin extension trial, which found that the efficacy of Ebglyss was equivalent when dosed every four or eight weeks for moderate-to-severe atopic dermatitis.

Ebglyss was first cleared in Europe in 2023, with approvals in the US, Japan, and Canada in 2024, and made $408 million in revenues for Lilly in 2025, its first full year on the market, while Almirall booked around $125 million in Europe.

Along with the new maintenance dosing, Lilly also reported clinical trial data in March that could be used to expand its label to include younger patients, aged six months and over. The drug is currently approved for use in adults and children aged over 12.