FDA Approves EBGLYSS 8-Week Dosing

The U.S. Food and Drug Administration (FDA) has approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of Eli Lilly and Company’s 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.

“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, EVP 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.

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.

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