ZUG, Switzerland - Friday, 13. December 2024 AETOSWire
Atopic dermatitis is a common, chronic, and flaring inflammatory skin
disease characterized by persistent itch and recurrent skin lesions, and
affects approximately up to 40 million people in the European Union
(EU)1-4
Prurigo nodularis is a serious skin disease characterized
by chronic itch, skin nodules covering large body areas, and poor sleep
quality, which is estimated to affect up to 111 people per 100,000 in
the EU5-10
Nemolizumab is a first-in-class monoclonal antibody
that specifically targets IL-31 receptor alpha, inhibiting the signaling
of IL-31.2 IL-31 is a neuroimmune cytokine that drives itch and is
involved in inflammation and skin barrier dysfunction in both atopic
dermatitis and prurigo nodularis11-13
This positive opinion from
the European Medicines Agency (EMA)’s Committee for Medicinal Products
for Human Use (CHMP) recommending the granting of marketing
authorization of nemolizumab in the European Union (EU) for the
treatment of both atopic dermatitis and prurigo nodularis follows the
United States Food and Drug Administration’s approval of nemolizumab for
the treatment of adults with prurigo nodularis earlier in August 202414
(BUSINESS
WIRE) -- Galderma today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion and recommended granting the marketing
authorization of nemolizumab for the treatment of both atopic dermatitis
and prurigo nodularis in the European Union (EU). The CHMP has
recommended nemolizumab’s approval for subcutaneous use for the
treatment of moderate-to-severe atopic dermatitis in patients aged 12
years and older who are candidates for systemic therapy, and for
subcutaneous use for the treatment of adults with moderate-to-severe
prurigo nodularis who are candidates for systemic therapy. This follows
its approval for the treatment of adults with prurigo nodularis by the
United States (U.S.) Food and Drug Administration (FDA) in August
2024.14
Atopic dermatitis is a common, chronic, and flaring
inflammatory skin disease which affects approximately 10 to 40 million
people in the EU, with up to 66% of adults suffering with a
moderate-to-severe form of the condition.1-4,15 Often reported as one of
patients’ most problematic symptoms, 87% of people with atopic
dermatitis say they are seeking freedom from itch, with speed of itch
relief therefore also prioritized by both patients and physicians.16-19
Atopic dermatitis is also a highly heterogenous disease and can be
associated with several comorbid conditions, namely mental health
disorders and other autoimmune- or immune-mediated diseases.20,21
Prurigo
nodularis is a serious skin condition characterized by several
debilitating symptoms, including chronic itch, skin nodules covering
large body areas, and poor sleep quality.5-7,10 The condition is
underrecognized and underdiagnosed, and its prevalence is not
well-documented, but it is estimated to affect between 7-111 people per
100,000 in the EU depending on the country.8,9,12
Given the
significant burden these serious diseases place on patients, their
families, and caregivers, there is a need for alternative treatment
options that may effectively relieve the signs and symptoms.22,23
“The
robust evidence base we have built for nemolizumab in both atopic
dermatitis and prurigo nodularis shows the extent of its potential in
improving outcomes for these diseases where the burden and unmet needs
remain high. We now await the European Commission’s approval decision
and hope to be able to bring nemolizumab to patients in the European
Union in due course.”
FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA
This
positive CHMP opinion is based on robust results from the phase III
ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and
prurigo nodularis, respectively.
The phase III ARCADIA 1 and 2
trials evaluated the efficacy and safety of nemolizumab in 1,728
adolescent and adult patients with moderate-to-severe atopic dermatitis.
Results demonstrated that patients treated with nemolizumab,
administered subcutaneously every four weeks in combination with
background topical corticosteroids (TCS), with or without topical
calcineurin inhibitors (TCI), showed statistically significant
improvements in co-primary and key secondary endpoints, when compared to
placebo in combination with TCS, with or without TCI, after 16 weeks of
treatment, with significant itch relief observed as early as Week 1.24
The
phase III OLYMPIA 1 and 2 trials evaluated the efficacy and safety of
nemolizumab administered subcutaneously every four weeks in more than
500 patients with prurigo nodularis. The trials met both their primary
and key secondary endpoints, demonstrating that treatment with
nemolizumab resulted in significant and clinically meaningful
improvements in itch and skin nodules at Week 16, with rapid reductions
in itch observed as early as Week 4.25,26
Nemolizumab was well
tolerated in both trials, and its safety profile was generally
consistent with earlier data, and between trials.24-26
The
positive CHMP opinion will now be sent to the European Commission for
the adoption of a decision on an EU-wide marketing authorization. If
approved, nemolizumab would be the first monoclonal antibody treatment
available for patients in the EU that specifically targets IL-31
receptor alpha, inhibiting the signaling of IL-31.2 IL-31 is a
neuroimmune cytokine that drives itch and is involved in inflammation
and skin barrier dysfunction in both atopic dermatitis and prurigo
nodularis.11-13
“This positive opinion represents an
encouraging step forward for patients in the EU with atopic dermatitis
and prurigo nodularis, given the profound impact these conditions have
on the lives of patients and their loved ones. With unrelenting itch,
accompanied by skin lesions as well as potential mental health
implications, new treatment options that have the potential to quickly
and effectively treat these conditions are essential.”
PROFESSOR DIAMANT THAÇI
LEAD INVESTIGATOR OF THE ARCADIA LONG-TERM EXTENSION STUDY
UNIVERSITY OF LUBECK, GERMANY
This
positive opinion from the CHMP follows the U.S. FDA’s approval of
nemolizumab (marketed as Nemluvio®) as a pre-filled pen for subcutaneous
injection for the treatment of adults with prurigo nodularis in August
2024.14 The U.S. FDA’s review of Galderma’s Biologics License
Application for nemolizumab for the treatment of moderate-to-severe
atopic dermatitis is currently ongoing, with a decision anticipated
soon. Galderma also has marketing authorization applications for
nemolizumab in both atopic dermatitis and prurigo nodularis under review
by multiple additional regulatory authorities, including via the Access
Consortium framework in countries such as Australia, Singapore, and
Switzerland, as well as in Canada, Brazil, and South Korea. Further
submissions to other regulatory authorities will continue throughout the
coming months.
Media can find more information about atopic dermatitis and prurigo nodularis here.
About nemolizumab
Nemolizumab
was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016,
Galderma obtained exclusive rights to the development and marketing of
nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab
is marketed as Mitchga® and is approved for the treatment of prurigo
nodularis, as well as pruritus associated with atopic dermatitis in
pediatric, adolescent, and adult patients.27,28
About the OLYMPIA clinical trial program25,26,29,30
The
OLYMPIA program included two identically designed, pivotal phase III
clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2.
This is the largest clinical trial program conducted in prurigo
nodularis to date, and the only program to include a long-term extension
study.
These global, randomized, double-blind,
placebo-controlled phase III clinical trials assessed the efficacy and
safety of nemolizumab monotherapy compared with placebo in patients at
least 18 years of age with moderate-to-severe prurigo nodularis over a
16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1,
respectively.
About prurigo nodularis
Prurigo nodularis is
a chronic, debilitating, and distinct neuroimmune skin disease
characterized by the presence of intense itch and thick skin nodules
covering large body areas.6 The majority of patients report that the
persistent itch negatively impacts their quality of life.31 Furthermore,
the intense itch associated with prurigo nodularis results in
significant sleep disturbance and further contributes to reduced quality
of life.10,32
About the ARCADIA clinical trial program24,33,34
The
ARCADIA program included two identically designed, pivotal phase III
clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and
ARCADIA 2.
These global, randomized, multicenter, double-blind,
placebo-controlled phase III clinical trials, evaluated the efficacy and
safety of nemolizumab administered subcutaneously every four weeks
compared to placebo (both administered with background topical
corticosteroids with or without topical calcineurin inhibitors).
The
trials were conducted in adolescent and adult patients (12 years and
over) with moderate-to-severe atopic dermatitis for an initial treatment
phase of 16 weeks. Patients who responded to treatment (defined as
patients who achieved an investigator’s global assessment score of clear
(0) or almost clear (1), or a 75% or greater improvement in the eczema
area and severity index score) were then re-randomized to a maintenance
treatment phase for up to 48 weeks.
About atopic dermatitis
Atopic
dermatitis is a common, chronic, and flaring inflammatory skin disease,
characterized by persistent itch and recurrent skin lesions.1-3 It is
the most common inflammatory skin disease, impacting almost four times
more people than psoriasis.2,3,35 While currently available treatments
may improve some signs and symptoms of the disease, many patients do not
respond optimally to approved therapies and do not experience itch
relief and clear skin to the same degree.2,13,23,36
About Galderma
Galderma
(SIX: GALD) is the pure-play dermatology category leader, present in
approximately 90 countries. We deliver an innovative, science-based
portfolio of premium flagship brands and services that span the full
spectrum of the fast-growing dermatology market through Injectable
Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since
our foundation in 1981, we have dedicated our focus and passion to the
human body’s largest organ – the skin – meeting individual consumer and
patient needs with superior outcomes in partnership with healthcare
professionals. Because we understand that the skin we are in shapes our
lives, we are advancing dermatology for every skin story. For more
information: www.galderma.com.
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Langan SM, et al. Atopic
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Pereira MP, et al. European Academy of Dermatology and Venereology
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doi:10.1002/cti2.1390
NEMLUVIO (nemolizumab-ilto) injection 30 mg Prescribing Information. Dallas, TX: Galderma Laboratories, L.P.; August 2024
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doi:10.1111/1346-8138.15090
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Contacts
For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12
Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85
Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43
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