- LEO Pharma is expanding upon its ambitions in the United States
(U.S.) as the FDA has accepted for filing the company’s New Drug
Application (NDA) for delgocitinib cream, an investigational
innovative topical treatment for Chronic Hand Eczema (CHE).
- The application has been accepted for filing and, if approved,
delgocitinib cream would become the first treatment in the U.S.
specifically indicated for adults with moderate to severe CHE.
- CHE is a condition with a high unmet need that affects
approximately 4.7% of the population globally.1
NOT FOR UK USE – NOT INTENDED FOR UK MEDIA
LEO Pharma Inc. announced today that the Food and Drug
Administration (FDA) has accepted for filing a New Drug Application
(NDA) for delgocitinib cream 20 mg/g (2%) for the treatment of
adults with moderate to severe Chronic Hand Eczema (CHE), who have
had an inadequate response to, or for whom topical corticosteroids
are not advisable.
This marks an important next step on LEO Pharma’s path to
providing delgocitinib cream to adults living with moderate to
severe CHE, a condition for which there are currently no FDA
approved treatments. This news is the latest in a series of
regulatory milestones globally. Today LEO Pharma also announced the
European Commission (EC) approval for delgocitinib cream in the
European Union (EU).2
“Our hands are integral to every practical aspect of our lives,
from our ability to work, to connecting with loved ones. Today, I
am incredibly proud that LEO Pharma is taking a step towards
addressing the long-standing unmet need in CHE for those in the
U.S.” said Christophe Bourdon, CEO of LEO Pharma A/S. “This news is
testament to our dedication to making a fundamental difference for
those who need us most in medical dermatology. Alongside our
ongoing efforts in Europe, we will approach our work to provide
delgocitinib cream in the U.S. with the same determination and
dedication.”
The regulatory submission for delgocitinib cream is based on
results from the phase 3 program, which includes the DELTA 1 and
DELTA 2 clinical trials that evaluated the safety and efficacy of
delgocitinib cream compared to cream vehicle.3-5 Both trials met
their primary and all secondary endpoints.6,7
Subjects who completed the 16-week DELTA 1 or DELTA 2 trials
were extended the offer to enroll in the 36-week DELTA 3 open-label
extension trial.8,9
Delgocitinib cream is an investigational topical pan-JAK
inhibitor for the treatment of moderate to severe CHE in adults. It
inhibits the activation of JAK-STAT signaling, which plays a key
role in the pathogenesis of CHE.10
“Dermatologists regularly see the true extent to which CHE
impacts patients’ lives through unique physical and psychological
challenges,” said Christopher Bunick, MD, PhD, Associate Professor
of Dermatology, Yale Medical School. "Many patients need more
options beyond traditional topical corticosteroid use, so I welcome
today’s news, which brings the prospect of a potential new
treatment option one step closer for those across the U.S. living
with this debilitating condition.”
CHE is a heterogeneous, fluctuating, inflammatory skin disease
with key symptoms of itch and pain. Its pathophysiology is
characterized by skin barrier dysfunction, skin inflammation, and
skin microbiome alterations.11 The condition can have a high
psychological, social, and occupational burden.12-14
“Over the last few years, we have significantly strengthened our
presence in the U.S. through a determined effort to support
dermatologists in making a difference for those living with skin
conditions,” said Brian Hilberdink, EVP and President, Region North
America, LEO Pharma. “With today’s announcement, we reinforce our
commitment to addressing the high unmet need of U.S. patients
living with CHE, a condition that can significantly impact quality
of life, including an impact to mental wellbeing. The announcement
of the filing of the NDA for delgocitinib cream is a validation of
our mission to advance the standard of care, and we are committed
to working closely with the FDA in the coming months during its
review.”
The regulatory review process is expected to conclude in the
second half of 2025.
Notes to editors
About the DELTA 1, 2 and 3 Trials
The primary objective for the randomized, double-blind,
vehicle-controlled, multi-center phase 3 clinical trials (DELTA 1
and DELTA 2) was to evaluate the efficacy of twice-daily
applications of delgocitinib cream 20 mg/g (2%) compared with cream
vehicle in the treatment of adults with moderate to severe
CHE.3-5
The primary endpoint of the trials was the Investigator’s Global
Assessment for Chronic Hand Eczema treatment success (IGA-CHE TS)
at Week 16. Treatment success was defined as an IGA-CHE score of 0
(clear) or 1 (almost clear) with at least a two-step improvement
from baseline. Additional IGA-CHE scores included 2 (mild), 3
(moderate), and 4 (severe).3-5
Key secondary endpoints at Week 16 included reduction of itch
and pain scores of ≥4 points measured by the Hand Eczema Symptom
Diary (HESD) from baseline to Week 16, as well as at least 75%
improvement from baseline and at least 90% improvement from
baseline on the Hand Eczema Severity Index (HECSI) at Week 16. The
number of treatment-emergent adverse events from baseline to Week
16 defined the key safety endpoint of the trials.3-5
Subjects who completed 16 weeks of treatment with delgocitinib
cream or cream vehicle twice daily in trials DELTA 1 or DELTA 2
were offered to roll-over to the 36-week DELTA 3 Open-label,
Multi-site Extension trial. The purpose of this extension trial was
to evaluate the long-term safety of delgocitinib.8
About Chronic Hand Eczema
Chronic Hand Eczema (CHE) is defined as hand eczema (HE) that
lasts for more than three months or relapses twice or more within a
year.15,16 CHE is one of the most common skin disorders of the
hands with a prevalence rate of approximately 4.7%.1 In a
substantial number of patients, HE can develop into a chronic
condition.17 CHE is a fluctuating disorder characterized by itch
and pain, and patients may experience signs such as erythema,
scaling, lichenification, hyperkeratosis, vesicles, edema, and
fissures on hands and wrists.12
CHE has been shown to cause psychological and functional burdens
that impact patient quality of life,13 with approximately 70% of
individuals who live with severe CHE admitting to problems in
performing everyday activities, and suffering disruption in their
daily life due to the condition.19 Furthermore, careers and earning
potential have also been shown to be impacted by the burden of
living with CHE.20
About Delgocitinib Cream
Delgocitinib Cream, which is marketed in the EU under the
tradename Anzupgo® (delgocitinib) Cream, is an investigational
topical pan-Janus kinase (JAK) inhibitor for moderate to severe
CHE. It inhibits the activation of JAK-STAT signaling, which plays
a key role in the pathogenesis of CHE.11 The pathophysiology is
characterized by skin barrier dysfunction, inflammation of the
skin, and alterations of the skin microbiome.11 LEO Pharma is
currently developing delgocitinib cream formulation for the
treatment of moderate to severe Chronic Hand Eczema (CHE) in
adults, which is currently not approved by any health authority. In
2014, LEO Pharma A/S and Japan Tobacco Inc. (JT) entered into a
license agreement in which LEO Pharma gained exclusive rights to
develop and commercialize delgocitinib cream for topical use in
dermatological indications worldwide, excluding Japan, where JT
retains rights.
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the
standard of care for the benefit of people with skin conditions,
their families and society. Founded in 1908 and majority owned by
the LEO Foundation, LEO Pharma has devoted decades of research and
development to advance the science of dermatology, and today, the
company offers a wide range of therapies for all disease
severities. LEO Pharma is headquartered in Denmark with a global
team of 4,200 people, serving millions of patients across the
world. In 2023, the company generated net sales of DKK 11.4
billion.
Contact:
References
- Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic
Hand Eczema in adults: A cross-sectional multi-national study of
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04-07 2024; Dresden, Germany. Poster presentation #3
- Delgocitinib SmPC; September 2024
- ClinicalTrials.gov. National Library of Medicine (U.S.).
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https://clinicaltrials.gov/ct2/show/NCT04872101.
- ClinicalTrials.gov. National Library of Medicine (U.S.).
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https://clinicaltrials.gov/ct2/show/NCT04872101.
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Eczema: results of the Phase 3 open-label extension DELTA-3 trial.
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- Thyssen, et al. The epidemiology of hand eczema in the general
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MAT-76480 September 2024
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version on businesswire.com: https://www.businesswire.com/news/home/20240923600460/en/
Jes Broe Frederiksen LEO Pharma, Senior Manager, Global Product
and Data Communications Tel: +45 53 60 59 48 Email:
jebfe@leo-pharma.com
Melissa Borland LEO Pharma, Senior Manager, Communications –
North America Tel: + 1 647 241 1475 Email: MQBCA@leo-pharma.com