Eli Lilly and Company (LLY) announced that the U.S. Food and Drug Administration (FDA) has approved an every-eight-week maintenance dosing schedule for EBGLYSS or lebrikizumab-lbkz (250 mg/2 mL) 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. EBGLYSS is a monoclonal antibody used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg).
The current extended approval was backed by longitudinal exposure-response modelling 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.
No new safety signals were observed during the 32-week, every-eight-week extension phase of the ADjoin study, according to the firm.
"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.
Lilly has exclusive rights in the US for the development and commercialisation of EBGLYSS, and Almirall has licensed the rights to develop and commercialise EBGLYSS for the treatment of dermatology indications, including atopic dermatitis, in Europe.
For the first quarter of 2026, Lilly's revenue increased 56% to $19.80 billion, up from $12.73 billion in the prior year.
In the first quarter, EBGLYSS sales rose 141% to $145 million from $60 million in the prior year.
Net income improved 155% to $7.663 billion or $8.55 per share from $3.004 billion or $3.34 per share in the prior year.
LLY has traded between $623.78 and $1,182.73 over the last year. The stock closed Tuesday's trade at $1144.68, down 0.39%.
In the overnight market, LLY is down 0.31% at $1141.09.
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