- Lebrikizumab is recommended by NICE for the use in moderate to
severe Atopic Dermatitis in patients 12 years and over when their
condition has not responded to at least 1 systemic
immunosuppressant, or when these treatments are not suitable
- Following approval of the European Commission (October 2023)
and the MHRA (December 2023), lebrikizumab will be available for
prescription through the NHS in England and Wales
- Lebrikizumab is a monoclonal antibody that binds to
Interleukin-13 with high affinity, selectively inhibiting its
downstream signalling1-4
Almirall S.A. (BME: ALM), a global biopharmaceutical company
dedicated to medical dermatology, announced today that the National
Institute for Health and Care Excellence (NICE) has recommended
Ebglyss (lebrikizumab) for use in moderate to severe Atopic
Dermatitis in the NHS England.
Lebrikizumab is indicated for the treatment of adult and
adolescent patients (12 years and older with a body weight of at
least 40 kg) with moderate-to-severe Atopic Dermatitis (AD), who
are candidates for systemic therapy. The treatment was approved by
the European Commission and the UK’s Medicines and Healthcare
products Regulatory Agency (MHRA) in December 2023.
In the United Kingdom, approximately 5.2 million adults (7.7%,
18-74 years) and 2.5 million children (18%, 0-17 years) have
moderate or severe atopic dermatitis10, also commonly referred to
as atopic eczema.
“Most people have heard of atopic eczema, but don’t realise how
it can dominate the lives of patients and their families. As well
as the physical symptoms of itchy, sore, cracked, bleeding skin,
eczema can affect so many decisions a patient makes – every day;
from what to wear, activities they can and cannot participate in,
to managing time-consuming, messy skincare regimens,” explains
Andrew Proctor, National Eczema Society Chief Executive.
“The National Eczema Society welcomes the NICE recommendation for
lebrikizumab as an additional treatment for eligible people with
moderate to severe atopic eczema. It’s important we have a range of
treatment options, so patients have the chance to access a
treatment that works well for them.”
“The NICE recommendation for lebrikizumab for eligible people 12
years and over suffering with moderate-to-severe AD in England is
testament to the benefits this treatment can bring to patients due
to its demonstrated efficacy, with 4-weekly maintenance dosing and
an acceptable safety profile. This is well aligned with our company
purpose to transform the patient's world by helping them realize
their hopes and dreams for a healthy life," stated Jorgen
Damsbo, General Manager at Almirall, UK.
“Atopic dermatitis often has a greatly underestimated
psychosocial burden for the patients and their families. Both
adults and children frequently face stigmatisation, loss of
confidence and bullying, sleep deprivation and overwhelming itch,
which may impact their performance at school and work. In severe
atopic dermatitis, patients often suffer from depression, anxiety,
and even suicidal ideation. The addition of this targeted
biological therapy is an important step forward and most welcomed
for patients and clinicians alike,” said Prof Tony Bewley,
Consultant Dermatologist, Barts Health NHS Trust, and Honorary
Professor of Dermatology at QMUL.
“Atopic Dermatitis is a chronic, life-long condition, with no
cure. It is very encouraging to witness the increase in drug
development in Atopic Dermatitis, especially with biological
treatments, which can have a very beneficial effect on the
condition. That lebrikizumab is now reimbursed by NICE is great
news for patients as it adds another much-needed targeted biologic
to the treatment options already available for Atopic Dermatitis,”
said Prof Richard Weller, Professor of Medical Dermatology at
the University of Edinburgh, and Honorary Consultant
Dermatologist.
About lebrikizumab
Lebrikizumab is a monoclonal antibody that binds the cytokine
IL-13 with high affinity to specifically prevent the formation of
the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signalling,
thus inhibiting the biological effects of IL-13. Therefore,
inhibition of the IL-13 signalling is expected to be of benefit in
diseases in which IL-13 is a key contributor to the disease
pathogenesis. IL-13 is key in atopic dermatitis, driving the type-2
inflammatory loop in the skin, leading to skin barrier dysfunction,
itch, skin thickening and infection. Lebrikizumab represents a step
forward in patients with moderate-to-severe AD not controlled with
topical therapy due to its selective mechanism of action, proven
efficacy, acceptable safety profile, and a 4-weekly maintenance
dosing for all patients. Lebrikizumab demonstrated clinical
efficacy in both, monotherapy and in combination with topical
corticosteroids with 4-weekly maintenance dosing for all patients,
and has been approved by the EMA in October 20239. Clinical data up
to one year after first dosing have been published, as well as
interim clinical data up to two years after first dosing.5-8
About atopic dermatitis
AD, also referred to as atopic eczema, is a non-contagious
chronic, inflammatory disease of the skin characterized by
recurrent inflammation of the skin associated with intense pruritus
or itching. Beyond the evident physical manifestations such as
dryness, itchiness, redness, and inflammation, this condition can
exert profound emotional effects that can significantly disrupt the
academic, social, and professional lives of those affected. With an
estimated prevalence of up to 4.4% among adults in the EU, the
incidence of AD appears to have increased in recent decades, with
approximately 20-30% of patients having moderate-to-severe
disease.
About Almirall
Almirall is a global pharmaceutical company dedicated to medical
dermatology. We closely collaborate with leading scientists,
healthcare professionals, and patients to deliver our purpose: to
transform the patients' world by helping them realize their hopes
and dreams for a healthy life. We are at the forefront of science
to deliver ground-breaking, differentiated medical dermatology
innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is
publicly traded on the Spanish Stock Exchange (ticker: ALM).
Almirall (total revenue in 2023: €898.8 MM, 1900 employees
globally) has direct presence in 21 countries and marketed products
in over 100.
For more information, please visit almirall.com
Legal warning
This document includes only summary information and is not
intended to be exhaustive. The facts, figures and opinions
contained in this document, in addition to the historical ones, are
"forward-looking statements". These statements are based on the
information currently available and the best estimates and
assumptions that the company considers reasonable. These statements
involve risks and uncertainties beyond the control of the company.
Therefore, actual results may differ materially from those declared
by such forward-looking statements. The company expressly waives
any obligation to revise or update any forward-looking statements,
goals or estimates contained in this document to reflect any
changes in the assumptions, events or circumstances on which such
forward-looking statements are based, unless required by the
applicable law.
References
1.
Moyle M, et al. Understanding the immune
landscape in atopic dermatitis: The era of biologics and emerging
therapeutic approaches. Exp Dermatol. 2019;28(7):756–768.
2.
Gonçalves F, et al. Selective IL-13
inhibitors for the treatment of atopic dermatitis. Drugs Context.
2021;10:2021-1-7.
3.
Okragly A, et al. Binding, Neutralization
and Internalization of the Interleukin-13 Antibody, Lebrikizumab.
Dermatol Ther (Heidelb). 2023;13(7):1535-1547.
4.
Ultsch M, et al. Structural Basis of
Signaling Blockade by Anti-IL-13 Antibody Lebrikizumab. J Mol Biol.
2013;425(8):1330-1339.
5.
Silverberg JI, Guttman-Yassky E, Thaçi D,
et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe
Atopic Dermatitis. N Engl J Med.
2023;doi:10.1056/NEJMoa2206714.
6.
Simpson EL et al. Efficacy and safety of
Lebrikizumab in combination with topical corticosteroids in
adolescents and adults with moderate-to-severe atopic dermatitis: a
randomized clinical trial (ADhere). JAMA Dermatol. Published online
January 11, 2023; doi:10.1001/jamadermatol.2022.5534.
7.
Blauvelt A, et al. Efficacy and safety of
lebrikizumab in moderate-to-severe atopic dermatitis: 52-week
results of two randomized double-blinded placebo-controlled phase
III trials. British Journal of Dermatology. 2023; ljad022,
https://doi.org/10.1093/bjd/ljad022.
8.
Guttman-Yassky E, et al. Efficacy and
Safety of Lebrikizumab Is Maintained to Two Years in Patients With
Moderate-to-Severe Atopic Dermatitis. Presented at the Fall
Clinical Dermatology Conference; October 20, 2023.
9.
EBGLYSS (lebrikizumab). EU Summary of
Product Characteristics.
10.
Chan LN, Magyari A, Ye M, et al. The
epidemiology of atopic dermatitis in older adults: A
population-based study in the United Kingdom. PLoS One
2021;16(10):e0258219
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