New drug for atopic dermatitis (AD)! IL-13 inhibitor lebrikizumab enters review in the EU: long-lasting removal of skin lesions, relieves itching!

October 31, 2022 /BioValleyBIOON/ --Almirall is a global biopharmaceutical company
focused on skin health.
Recently, the company announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA)
for the treatment of moderate to severe atopic dermatitis (AD), a new anti-inflammatory drug IL-13 inhibitor lebrikizumab.
Almirall expects lebrikizumab to be approved in Europe in the first half of 2023, and the drug has the potential to provide patients with a best-in-class treatment option
.
AD is a chronic inflammatory skin disease that affects up to 4.
4% of adults in the EU, and the prevalence appears to have increased
over the past few decades.

Lebrikizumab MAA is based on 3 pivotal Phase 3 clinical studies
.
The ADvocate 1 study and the ADvocate2 study evaluated lebrikizumab as monotherapy for adults and adolescents with moderate to severe AD (aged 12 to under 18 years weighing at least 40 kg); The ADhere study evaluated lebikizumb in combination
with topical corticosteroids (TCS).
Results showed that patients who received lebrikizumab (every 2 weeks) during the 16-week induction phase of two monotherapy trials (ADvocate 1 and 2) and achieved a clinical response at week 16 continued to receive lebrikizumab during the maintenance phase for up to one year, achieving durable lesion clearance and itching relief
.
The results also showed that the maintenance phase lebrikizumab every 4 weeks regimen had similar efficacy
to the once every 2 weeks regimen after receiving lebrikizumab (every 2 weeks) during the 16-week induction phase.

Lebrikizumab is a novel monoclonal antibody (mAb) that binds soluble IL-13 with high affinity, high bioavailability, long half-life, and blocks IL-13 signaling
.

Almirall has been licensed to develop and commercialize lebrikizumab in Europe for the treatment of skin disease indications
including AD.
Eli Lilly owns exclusive rights to
develop and commercialize Lebrikizab in the United States and countries outside of Europe.
Previously, the US FDA had granted Fast Track Qualification (FTD)
to lebrikizumab for the treatment of adults and adolescents with moderate to severe AD (ages 12 to under 18 years weighing ≥ 40 kg).

Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin disease
caused by skin barrier dysfunction and a dysregulated immune response.
People with AD often report intense, persistent itching that is very uncomfortable and can interfere with sleep, daily activities, and social relationships
.
In AD patients, the IL-13 protein (the central causative mediator of the disease) is overexpressed, which drives multiple aspects of AD pathophysiology by promoting inflammation of helper T cell 2 (Th2) cells, leading to skin barrier dysfunction, pruritus, infection, hardening and thickening
of the skin area.

Lebrikizumab mechanism of action (click on the image for a larger image, source: mosmedpreparaty.
ru)

In June this year, Lilly announced the top-line results
of a one-year analysis of the efficacy and safety of two pivotal Phase 3 clinical studies (ADvocate 1, ADvocate 2) of lebrikizumab in the treatment of moderate to severe atopic dermatitis (AD).
。 The two studies evaluated the efficacy and safety of lebrikizumab as monotherapy in adults and adolescents with moderate to severe AD (aged 12 to under 18 years weighing at least 40 kg), with the primary efficacy endpoint assessed at week 16: complete or near-complete clearance (IGA score of 1) as total investigator assessment (IGA score of 0) and improvement from baseline ≥ 2 points, Eczema Area and Severity Index (EASI) scores improved by ≥ 75%
from baseline.

Previously published 16-week results showed that both studies met both primary and all secondary endpoints, including lesion clearance, improvement in pruritus, and improvement
in quality of life.
With EASI assessment, eczema area and severity index (EASI) scores improved by ≥ 75% from baseline (EASI-75).

The new data released this time show that in two studies: patients who achieved a clinical response (EASI-75) after 16 weeks of treatment, about 80% of patients who received a regimen of lebrikizumab every 2 weeks or every 4 weeks for one year still maintained skin lesion clearance
.
In addition, during the one-year period, the patient continues to maintain itching relief
.

Specifically: In the ADvocate 1 study, 79% of patients treated with lebrikizumab every 4 weeks and 75% of patients who received every 2 weeks maintained EASI-75
after one year of treatment.
In the ADvocate 2 study, 85% of patients treated with lebrikizumab every 4 weeks and 79% who received every 2 weeks maintained EASI-75
after one year of treatment.
In patients treated with lebrikizumab, the frequency of adverse events and the overall safety profile were consistent
with the induction period of the trial and previous studies of lebrikizumab AD.
No new safety signals
were observed in this patient population.
(Bio Valley Bioon.
com)

Almirall announces EMA acceptance for filing of Marketing Authorization Application (MAA) for lebrikizumab in atopic dermatitis