Eli Lilly’s Ebglyss (lebrikizumab) has been approved by the US FDA as a maintenance dose for patients with moderate-to-severe atopic dermatitis.
The subcutaneous maintenance dose is given once every eight weeks as a single injection (250 mg/2 mL). It is suitable for use by adults and children with moderate-to-severe atopic dermatitis who are 12 years of age and older and weigh at least 88 pounds (40 kg).
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.
Adrienne Brown, executive vice president and president of Lilly Immunology, said: “This 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.”
The approval is based on 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.
“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 and the most common (≥1%) adverse reactions reported are conjunctivitis, injection site reactions and herpes zoster.
Lilly has exclusive rights for development and commercialisation of Ebglyss in the US and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialise Ebglyss for the treatment of dermatology indications, including atopic dermatitis, in Europe.