Galderma Receives Filing Acceptances for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in Four Additional Countries
May 07 2024 - 1:00AM
Business Wire
- Galderma has received filing acceptances for nemolizumab for
the treatment of patients with prurigo nodularis and for
adolescents and adults with moderate-to-severe atopic dermatitis in
Australia, Singapore, Switzerland, and the United Kingdom, via the
Access Consortium framework
- The U.S. Food and Drug Administration and European Medicines
Agency also accepted filing submissions for nemolizumab for the
treatment of prurigo nodularis and atopic dermatitis in February
2024, with U.S. decisions anticipated this year
- Further submissions to regulatory authorities in additional
countries are ongoing
Galderma today announced that it has received filing acceptances
for nemolizumab for the treatment of patients with prurigo
nodularis and for adolescents and adults with moderate-to-severe
atopic dermatitis in Australia, Singapore, Switzerland, and the
United Kingdom, whose regulatory authorities are members of the
Access Consortium. An approval decision is expected from the
consortium next year. Nemolizumab is a therapy specifically
inhibiting IL-31 signaling to provide safe and rapid relief from
the most burdensome symptom of both skin conditions: itch.1-7
The Access Consortium is a collaborative initiative comprised of
regulatory authorities which work together to address shared
challenges, sharing knowledge and promoting greater collaboration
to make regulatory systems more efficient.8
These acceptances are in addition to those received from the
U.S. Food and Drug Administration (FDA) and European Medicines
Agency for nemolizumab for the treatment of prurigo nodularis and
atopic dermatitis in February 2024. Nemolizumab was also granted
Breakthrough Therapy designation by the U.S. FDA in December 2019
for the treatment of pruritus associated with prurigo nodularis, a
status reconfirmed in March 2023. The U.S. FDA subsequently granted
nemolizumab Priority Review for the treatment of prurigo nodularis;
its decisions on prurigo nodularis and atopic dermatitis are
anticipated this year. Further submissions to regulatory
authorities in additional countries are ongoing.
“These four new filing
acceptances once again reinforce the potential blockbuster status
of nemolizumab, which has shown great promise in both prurigo
nodularis and atopic dermatitis. With even more filings anticipated
this year, we are looking forward to finally bringing this
long-awaited therapy to patients with these serious conditions as
soon as possible, given the high burden of disease they still
face.”
BALDO SCASSELLATI SFORZOLINI,
M.D., Ph.D.
GLOBAL HEAD OF R&D
GALDERMA
The regulatory submissions of nemolizumab in prurigo nodularis
are based on data from the phase III OLYMPIA clinical trial
program, which evaluated the efficacy and safety of nemolizumab
administered subcutaneously every four weeks in patients with
prurigo nodularis.9,10 Both trials in the OLYMPIA program met all
primary and key secondary endpoints. Results demonstrated
nemolizumab’s ability to rapidly improve itch, clear skin nodules
and reduce sleep disturbance, with sustained improvements for up to
one year.11-13
The regulatory submissions of nemolizumab in atopic dermatitis
are based on data from the phase III ARCADIA clinical trial
program, which evaluated the efficacy and safety of nemolizumab
administered subcutaneously every four weeks in adolescents and
adults with moderate-to-severe atopic dermatitis.14,15 Both trials
in the ARCADIA program met all primary and key secondary endpoints.
Results showed that nemolizumab clinically improved skin lesions
and rapidly improved itch and sleep disturbance.16
Media can find more information about atopic dermatitis and
prurigo nodularis in this media toolkit.
About nemolizumab Nemolizumab was initially developed by
Chugai Pharmaceutical Co., Ltd., and subsequently licensed to
Galderma in 2016 worldwide, except in Japan and Taiwan. In Japan,
nemolizumab is approved for the treatment of pruritus associated
with atopic dermatitis and is in development for prurigo nodularis.
Nemolizumab is under regulatory review for the treatment of
patients with prurigo nodularis and moderate-to-severe atopic
dermatitis by the U.S. Food and Drug Administration and European
Medicines Agency, as well as in Australia, Singapore, Switzerland,
and the United Kingdom, via the Access Consortium framework.
Galderma has not received regulatory approval for nemolizumab for
any indication in any country to date.
About Galderma Galderma 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:
- 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
- Silverberg JI, et al. Patient burden and quality of life in
atopic dermatitis in US adults: a population-based cross-sectional
study. Ann Allergy Asthma Immunol. 2018;121(3):340-347.
doi:10.1016/j.anai.2018.07.006
- Bağci IS and Ruzicka T. IL-31: A new key player in dermatology
and beyond. J Allergy Clin Immunol. 2018;141(3):858-866.
doi:10.1016/j.jaci.2017.10.045
- Dillon SR, et al. Interleukin 31, a cytokine produced by
activated T cells, induces dermatitis in mice [published correction
appears in Nat Immunol. 2005;6(1):114]. Nat Immunol.
2004;5(7):752-760. doi: 10.1038/ni1084
- 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
- 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
- Halvorsen JA, et al. Suicidal ideation, mental health problems,
and social function in adolescents with eczema: a population-based
study. J Invest Dermatol. 2014;134(7):1847-1854.
doi:10.1038/jid.2014.70
- SwissMedic.ch. Access Consortium. Available online:
https://www.swissmedic.ch/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini.html
Last accessed April 2024
- ClinicalTrials.Gov. A Study to Assess the Efficacy and Safety
of Nemolizumab (CD14152) in Participants With Prurigo Nodularis
(PN). Available online:
https://clinicaltrials.gov/study/NCT04501679. Last accessed April
2024
- ClinicalTrials.Gov. An Efficacy and Safety Study of Nemolizumab
(CD14152) in Participants With Prurigo Nodularis. Available online:
https://clinicaltrials.gov/study/NCT04501666. Last accessed April 2024
- Kwatra SG, et al. Phase III trial of nemolizumab in patients
with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi:
10.1056/NEJMoa2301333
- 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, S, et al. Nemolizumab long-term efficacy and safety up
to 52 weeks in the OLYMPIA open-label extension study in patients
with prurigo nodularis: an interim analysis. Late-breaking abstract
presented at AAD 2024
- ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in
Subjects With Moderate-to-Severe Atopic Dermatitis. Available
online: https://clinicaltrials.gov/study/NCT03989349. Last accessed
April 2024
- ClinicalTrials.Gov. Efficacy & Safety of Nemolizumab in
Subjects With Moderate-to-Severe Atopic Dermatitis. Available
online: https://clinicaltrials.gov/study/NCT03985943. Last accessed April 2024
- Silverberg J, et al. Nemolizumab improves skin lesions, itch
and sleep disturbance in patients with moderate-to-severe atopic
dermatitis: Results from two identical phase 3 multinational
studies (ARCADIA 1 and ARCADIA 2). Late-breaking abstract presented
at EADV 2023
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For further information:
Christian Marcoux, M.Sc. Chief Communications Officer
christian.marcoux@galderma.com +41 76 315 26 50
Sébastien Cros Corporate Communications Director
sebastien.cros@galderma.com +41 79 529 59 85
Emil Ivanov Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com +41 21 642 78 12
Jessica Cohen Investor Relations and Strategy Director
jessica.cohen@galderma.com +41 21 642 76 43