Ebglyss FDA Approval History
Last updated by Melisa Puckey, BPharm on Sep 16, 2024.
FDA Approved: Yes (First approved September 13, 2024)
Brand name: Ebglyss
Generic name: lebrikizumab-lbkz
Dosage form: injection
Company: Eli Lilly and Company
Treatment for: Atopic Dermatitis
Ebglyss (lebrikizumab-lbkz) is a targeted IL-13 inhibitor used for the treatment of moderate-to-severe atopic dermatitis (eczema) in adults and children 12 years and older who weigh at least 88 pounds (40 kg).
- Ebglyss (lebrikizumab-lbkz) is a treatment for moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies. It can be used in adults and children 12 years and older who weigh at least 88 pounds (40 kg).
- Ebglyss works by targeting eczema inflammation throughout the body to help improve dry, itchy, and irritated skin. In atopic eczema, a protein called IL-13 (Interleukin 13) is involved in the inflammation that causes atopic dermatitis.
- Ebglyss is an interleukin-13 antagonist that works by blocking IL-13, reducing inflammation, and improving atopic dermatitis symptoms.
- FDA approval of Ebglyss was based on results from ADvocate 1, ADvocate 2, and ADhere studies. Two studies (ADvocate 1 and 2) showed that 38% of people who took Ebgylyss achieved clear or almost-clear skin at 16 weeks (versus 12% with placebo), and 10% saw these results as early as four weeks.
- Ebglyss is given as a subcutaneous injection, two 250 mg injections at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when an adequate clinical response is achieved; then maintenance dosing is a single monthly injection (250 mg every four weeks).
- The most common Ebglyss side effects are eye and eyelid inflammation, including redness, swelling, and itching, injection site reactions, and shingles (herpes zoster).
- Ebglyss can cause serious side effects serious side effects, including allergic reactions that can be severe and also serious eye problems.
Development timeline for Ebglyss
Further information
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