Ad hoc announcement pursuant to Art. 53 LR
- Nemluvio® (nemolizumab) is the first approved monoclonal
antibody specifically inhibiting the signaling of IL-31, a
neuroimmune cytokine that drives multiple disease mechanisms in
prurigo nodularis1-3
- Prurigo nodularis is a chronic skin condition that is estimated
to affect up to 181,000 people in the United States, and is
characterized by persistent, intense itch4-8
- The U.S. Food and Drug Administration granted Nemluvio Priority
Review for the treatment of prurigo nodularis in February 2024,
following its Breakthrough Therapy Designation in 2019
- Further marketing authorization applications are under
regulatory review by multiple regulatory authorities, including the
European Medicines Agency and Health Canada
Galderma today announced that the U.S. Food and Drug
Administration (FDA) has approved Nemluvio® (nemolizumab) as a
pre-filled pen for subcutaneous injection for the treatment of
adults with prurigo nodularis.1 Nemluvio was granted Breakthrough
Therapy Designation in December 2019 and Priority Review in
February 2024 by the U.S. FDA – a status reserved for medicines
with the potential to significantly improve the treatment of
serious conditions.
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Prurigo nodularis is an underdiagnosed neuroimmune skin disease
which is estimated to affect up to 181,000 people in the United
States.7,8 This condition is characterized by several debilitating
symptoms, including chronic itch, skin nodules covering large body
areas, and poor sleep quality.5,9 Given the significant burden on
patients, there is a need for alternative treatment options that
may effectively relieve key signs and symptoms of the disease.10
Nemluvio specifically inhibits IL-31 cytokine signaling, which is
known to drive itch and is involved in inflammation, altered
epidermal differentiation, and fibrosis (hardening of skin tissue)
in prurigo nodularis.1-3,11,12
“The U.S. FDA’s rapid approval of
Nemluvio in prurigo nodularis is a first step in achieving its
blockbuster platform potential and reinforces our leadership in
therapeutic dermatology. We’re confident in the impact this
first-in-class therapy will have for patients with prurigo
nodularis who urgently need more treatment options and look forward
to potentially bringing Nemluvio to patients with other
itch-related skin diseases in the near future.”
FLEMMING ØRNSKOV, M.D., MPH
CHIEF EXECUTIVE OFFICER
GALDERMA
The approval is based on positive results from the phase III
OLYMPIA clinical trials – the largest clinical trial program
conducted in this condition to date – in which Nemluvio
demonstrated significant and clinically meaningful improvements in
itch and skin nodules at Week 16, with rapid reductions in itch
observed as early as Week 4.1,13-16
The phase III OLYMPIA 1 and OLYMPIA 2 clinical trials evaluated
the efficacy and safety of Nemluvio administered subcutaneously
every four weeks in more than 500 patients with prurigo
nodularis.13-16 The trials met both their primary and key secondary
endpoints, demonstrating that:
- 56% and 49% of Nemluvio-treated patients in OLYMPIA 1 and 2
respectively, achieved at least a four-point reduction in itch
intensity at Week 16, as measured by the peak-pruritus numerical
rating scale, compared to 16% in both placebo groups (p<0.001)
(primary endpoint).1
- 41% of Nemluvio-treated patients in OLYMPIA 1 and 2 achieved at
least a four-point reduction in itch intensity at Week 4, as
measured by the peak-pruritus numerical rating scale, compared to
6% and 7% in the placebo group (p<0.001) (key secondary
endpoint).1
- 26% and 38% of Nemluvio-treated patients in OLYMPIA 1 and 2
respectively, reached clearance (investigator’s global assessment
[IGA] 0) or almost-clearance (IGA 1) of skin nodules at Week 16,
when assessed using the IGA score (range: 0-4), compared to 7% and
11% in the placebo group (p<0.001) (primary endpoint).1
- 50% and 52% of Nemluvio-treated patients in OLYMPIA 1 and 2
respectively, achieved at least a four-point reduction in sleep
disturbance at Week 16, as measured by the sleep disturbance
numerical rating scale, compared to 12% and 21% in the placebo
group (p<0.001) (key secondary endpoint).15,16
The trials also met all other key secondary endpoints,
confirming rapid reduction of itch due to prurigo nodularis, and
sleep disturbance, within four weeks of treatment
initiation.1,15,16 Nemluvio was generally well tolerated, and its
safety profile was consistent with the phase II trial, and between
the OLYMPIA 1 and 2 trials.1,15,16
“I’m delighted that Nemluvio has
received U.S. FDA approval and I’m looking forward to offering this
treatment option to the prurigo nodularis patients in my practice
who are in desperate need of fast relief from itch, which
negatively impacts their quality of life. By inhibiting the
signaling of IL-31, Nemluvio addresses a key driver of prurigo
nodularis, safely and effectively improving itch as well as skin
nodules.”
DR. SHAWN KWATRA, M.D., PH.D.
LEAD INVESTIGATOR OF OLYMPIA
PROGRAM
JOSEPH W. BURNETT ENDOWED
PROFESSOR AND CHAIRMAN OF DERMATOLOGY
UNIVERSITY OF MARYLAND SCHOOL OF
MEDICINE
The U.S. FDA has also accepted for review the Biologics License
Application for Nemluvio for the treatment of moderate-to-severe
atopic dermatitis, with a decision anticipated later this year.
Galderma’s marketing authorization applications for Nemluvio in
both prurigo nodularis and atopic dermatitis are under review by
multiple regulatory authorities, including the European Medicines
Agency and Health Canada, as well as in Australia, Singapore,
Switzerland, and the United Kingdom, via the Access Consortium
framework. Further submissions to other regulatory authorities will
continue throughout 2024.
Media can find more information about prurigo nodularis in
this media toolkit.
About Nemluvio® (nemolizumab-ilto)
Nemluvio® (nemolizumab-ilto) 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.
Important Safety Information
Indication: NEMLUVIO® (nemolizumab-ilto) is a
prescription medicine used to treat adults with prurigo
nodularis.
Do not take NEMLUVIO if you are allergic to
nemolizumab-ilto or to any ingredients in NEMLUVIO. Before
taking NEMLUVIO, tell your healthcare provider about all of your
medical conditions, including if you:
- are scheduled to receive any vaccination. You should not
receive a live vaccine right before or during treatment with
NEMLUVIO.
- are pregnant or plan to become pregnant. It is not known
whether NEMLUVIO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether NEMLUVIO passes into your breast milk and if it can harm
your baby.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
NEMLUVIO may cause serious side effects, including: allergic
reactions (hypersensitivity). Stop using NEMLUVIO and tell your
healthcare provider or get emergency help right away if you get any
of the following symptoms:
- Breathing problems or wheezing
- Swelling of the face, lips, mouth, tongue, or throat
- Fainting, dizziness, feeling lightheaded
- Fast pulse
- Swollen lymph nodes
- Joint pain
- Fever
- Skin rash (red or rough skin)
- Nausea or vomiting
- General ill feeling
- Cramps in your stomach area
The most common side effects of NEMLUVIO include:
- Headache
- Skin rashes: eczema, atopic dermatitis (a type of eczema), and
eczema nummular (eczema presenting as scattered circular
patches)
These are not all of the possible side effects of NEMLUVIO. Call
your doctor for medical advice about side effects. You may report
side effects to the FDA at 1-800-FDA-1088.
Please see full Prescribing Information including Patient
Information.
About the phase III OLYMPIA clinical trial
program13-16
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.5 It is an
underrecognized and underdiagnosed skin condition, and while there
are limited studies investigating its prevalence, current estimates
indicate that up to 181,000 people are living with prurigo
nodularis in the United States.3,7,8,17 The majority of patients
report that the persistent itch negatively impacts their quality of
life.18 Furthermore, the intense itch associated with prurigo
nodularis results in significant sleep disturbance and further
contributes to reduced quality of life.9,19
About Galderma
Galderma (SIX: GALD) is the emerging 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.
References:
- Galderma data on file. Nemluvio U.S. Prescribing Information.
2024
- Silverberg JI, et al. Phase 2B randomized study of nemolizumab
in adults with moderate-to-severe atopic dermatitis and severe
pruritus. J Allergy Clin Immunol. 2020;145(1):173-182.
doi:10.1016/j.jaci.2019.08.013
- Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA
Blockade and Other Potential Treatments. Dermatol Ther (Heidelb).
2022;12(9):2039–2048. doi:10.1007/s13555- 022-00782-2
- Huang AH, et al. Prurigo nodularis: epidemiology and clinical
features. J Am Acad Dermatol. 2020;83(6):1559-1565.
doi:10.1016/j.jaad.2020.04.183
- Pereira MP, et al. European Academy of Dermatology and
Venereology European prurigo project: expert consensus on the
definition, classification and terminology of chronic prurigo. J
Eur Acad Dermatol Venereol. 2018;32(7):1059-1065.
doi:10.1111/jdv.14570
- Ständer S, et al. IFSI-guideline on chronic prurigo including
prurigo nodularis. Itch. 2020;5(4):e42.
doi:10.1097/itx.0000000000000042
- Kwatra SG, et al. Prevalence of prurigo nodularis in the United
States:, J Am Acad Dermatol Int. 2024.
doi:10.1016/j.jdin.2023.12.013.
- Ständer S, et al. Prevalence of prurigo nodularis in the United
States of America: A retrospective database analysis. J Am Acad
Dermatol Int. 2021;2:28-30.
- Kwatra SG. Breaking the itch–scratch cycle in prurigo
nodularis. N Engl J Med. 2020;382(8):757-758.
doi:10.1056/NEJMe1916733
- Chisolm SS. A Review of the Current Management and Burden of
Prurigo Nodularis in the United States. AJMC. 2023; 2023;29(suppl
5):S63-S72. doi.org/10.37765/ajmc.2023.89366
- Gibbs BF, Patsinakidis N, Raap U. Role of the pruritic cytokine
IL-31 in autoimmune skin diseases. Front Immunol. 2019;10:1383.
doi:10.3389/fimmu.2019.01383
- Yaseen B, Lopez H, Taki Z, et al. Interleukin-31 promotes
pathogenic mechanisms underlying skin and lung fibrosis in
scleroderma. Rheumatology (Oxford). 2020;59(9):2625-2636.
doi:10.1093/rheumatology/keaa195
- ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety
of Nemolizumab (CD14152) in Participants With Prurigo Nodularis
(PN). Available online. Accessed August 2024
- ClinicalTrials.Gov. An Efficacy and Safety Study of Nemolizumab
(CD14152) in Participants With Prurigo Nodularis. Available online.
Accessed August 2024
- Ständer S, et al. Nemolizumab monotherapy improves itch and
skin lesions in patients with moderate-to-severe prurigo nodularis:
Results from a global phase 3 trial (OLYMPIA 1): Late breaking
abstract presented at EADV 2023
- Kwatra SG, et al. Placebo-controlled phase III trial of
nemolizumab in patients with prurigo nodularis. N Engl J Med.
2023;389:1579-89. doi: 10.1056/NEJMoa2301333
- Huang AH, et al. Real-world prevalence of prurigo nodularis and
burden of associated diseases. J Invest Dermatol.
2020;140(2):480-483.e4 doi:10.1016/j.jid.2019.07.697
- Todberg T, et al. Treatment and burden of disease in a cohort
of patients with prurigo nodularis: a survey-based study. Acta Derm
Venereol. 2020;100(8):adv00119. doi:10.2340/00015555-3471
- Aggarwal P, et al. Clinical characteristics and disease burden
in prurigo nodularis. Clin Exp Dermatol. 2021;46(7):1277-1284.
doi:10.1111/ced.14722
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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