FDA approves targeted interleukin-13 inhibitor for moderate-to-severe atopic dermatitis
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Key takeaways:
- Ebglyss is a targeted interleukin-13 inhibitor approved for the treatment of moderate-to-severe atopic dermatitis.
- It can be used with or without topical corticosteroids.
Eli Lilly and Company announced it received FDA approval for Ebglyss for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with topical prescription therapies, according to a company press release.
According to the release, Ebglyss (lebrikizumab-lbkz) is a 250 mg/2 mL injection recommended for adults and children aged 12 years and older who weigh at least 88 pounds. The targeted interleukin-13 inhibitor can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection after the initial phase of treatment.
The release noted the approval of lebrikizumab-lbkz was based on results from the ADvocate 1, ADvocate 2 and ADhere studies, which demonstrated 38% of patients achieved clear or almost-clear skin at 16 weeks with lebrikizumab-lbkz. Clear or almost-clear skin was maintained in 77% of study participants at 1 year with once-monthly dosing.
Overall, 43% of the participants who were prescribed lebrikizumab-lbkz had itch relief at 16 weeks and 5% noted itch relief as early as 2 weeks, according to the release. In addition, 85% of participants who experienced itch relief at week 16 continued to have itch relief at 1 year of treatment with monthly maintenance dosing.
“People living with eczema have symptoms that can appear at the most inopportune times, creating unpredictability and impacting their everyday lives,” Daniel Skovronsky, MD, PhD, chief scientific officer and president of Lilly Research Laboratories and president of Lilly Immunology, said in the release. “Today’s approval allows people the opportunity to reimagine life with eczema as Ebglyss offers a targeted approach to reduce a main cause of eczema inflammation. Ebglyss provides long-lasting symptom relief with a convenient once-monthly maintenance dose.”
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