Ebglyss(lebrikizumab)

Immunology· 1434 cited findings· 1 source document

Company: Almirall S A

What the regulatory reviews say

Ebglyss (lebrikizumab) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older who are candidates for systemic therapy. The legal basis for its application is Article 8.3 of Directive 2001/83/EC, and a positive CHMP opinion was issued on 14 September 2023. A new active substance status was requested for Ebglyss.

In efficacy trials, 43.1% of patients achieved an IGA 0,1 with ≥2-Point reduction, compared to 12.7% in the placebo arm. Another trial showed 33.2% of patients achieving this endpoint, versus 10.8% in the placebo arm. When used with topical corticosteroids (TCS), 41.2% of patients achieved an IGA 0,1 with ≥2-Point reduction, compared to 22.1% in the placebo + TCS arm.

Regarding safety, the incidence of conjunctivitis was 8.5%, and keratitis was 0.6%. The embryo-fetal loss rate in the control group was 18.75%, while in the low dose group it was 12.5%, and in the high dose group it was 6.25%.

Key figures — cited to the source page

IGA 0,1 with ≥2-Point reduction	43.1	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.88
IGA 0,1 with ≥2-Point reduction (placebo)	12.7	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.88
IGA 0,1 with ≥2-Point reduction (with TCS)	41.2	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.89
IGA 0,1 with ≥2-Point reduction (placebo + TCS)	22.1	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.89
Conjunctivitis incidence	8.5	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.28
Keratitis incidence	0.6	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.28
Proposed indication	treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older who are candidates for systemic therapy	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.7
CHMP positive opinion date	14 September 2023	Almirall S A — Ebglyss EMA EPAR public assessment report (EM, p.9

Source documents

Almirall S A — Ebglyss EMA EPAR public assessment report (EMEA/H/C/005894, 2023) (2023)

Compared with

Dupixent vs Ebglyss

Explore the full evidence

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.