- The positive opinion marks the latest step towards marketing
authorization in the European Union (EU), with a final decision
from the European Commission (EC) now pending.
- If approved, delgocitinib cream will be the first topical
treatment specifically indicated for adults with moderate to severe
CHE for whom topical corticosteroids are inadequate or
inappropriate.
- The positive opinion is based on results from the DELTA phase 3
program, which includes the randomized, vehicle-controlled DELTA 1
and DELTA 2 clinical trials, 1,2,3 and the DELTA 3 open-label
extension trial.4
LEO Pharma A/S, a global leader in medical dermatology, today
announced that the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion that recommends the approval of Anzupgo® (delgocitinib
cream) for the treatment of adult patients with moderate to severe
chronic hand eczema (CHE), for whom topical corticosteroids are
inadequate or inappropriate.
Delgocitinib cream is an investigational topical pan-JAK
inhibitor for CHE. It inhibits the activation of JAK-STAT
signaling, which plays a key role in the pathogenesis of CHE.5
Currently, there are no topical treatments specifically approved
for adults with moderate to severe CHE for whom topical
corticosteroids are inadequate or inappropriate.
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.6 The condition has been proven to have
a high psychological, social, and occupational burden.7,8,9
“It is well known that CHE is challenging to live with and
manage, potentially impacting personal relationships and careers,”
said Christophe Bourdon, Chief Executive Officer, LEO Pharma.
“Despite the considerable burden of the condition, treatments
options approved for CHE have been limited. As an organization, we
are dedicated to helping advance the standard of care for the
benefit of people with skin conditions, and today we are one step
closer to addressing the unmet need that may be faced by those
living with CHE.”
The positive CHMP opinion 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.1,2,3 Both trials met
their primary and all secondary endpoints.10,11 Subjects who
completed the 16-week DELTA 1 or DELTA 2 trials were immediately
offered to enroll in the 36-week DELTA 3 open-label extension
trial.4 Results demonstrated a long-term safety profile consistent
with previous trial results.12
“The practical and highly visible location of CHE brings a
considerable burden,” said Kreesten Meldgaard Madsen, Chief
Development Officer, LEO Pharma. “Our hands are integral to every
aspect of our day to day lives, so avoiding physical triggers can
be challenging for people living with CHE. At the same time, the
highly visible area of this condition can have a negative impact
psychologically and emotionally. I am incredibly proud of this
milestone and we will now continue our work to support those living
with CHE.”
The CHMP’s positive opinion will be reviewed by the European
Commission (EC) and, pending the final decision, authorization of
delgocitinib cream will be valid in all EU member states, Iceland,
Norway, and Liechtenstein. Regulatory filings in other markets are
underway.
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 compared with cream vehicle in
the treatment of adults with moderate to severe CHE.1,2,3
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).1,2,3
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.1,2,3
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.4
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.13,14 HE is the most common skin disorder of the hands15 with
a one-year prevalence rate of approximately 9%.16 In a substantial
number of patients, HE can develop into a chronic condition.15 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.7
CHE has been shown to cause psychological and functional burdens
that impact patient quality of life,8 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.17 Furthermore, careers and earning
potential have also been shown to be impacted by the burden of
living with CHE.18
About Anzupgo® (delgocitinib cream)
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.4 The pathophysiology is
characterized by skin barrier dysfunction, inflammation of the
skin, and alterations of the skin microbiome.5 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.
References
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate
to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711.
https://clinicaltrials.gov/ct2/show/NCT04872101.
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Efficacy and Safety of Delgocitinib Cream in Adults With Moderate
to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101.
https://clinicaltrials.gov/ct2/show/NCT04872101.
- Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety
of delgocitinib cream in adults with moderate to severe chronic
hand eczema (DELTA 1 and DELTA 2): results from multicentre,
randomised, controlled, double-blind, phase 3 trials. Lancet 2024;
published online July 18.
https://doi.org/10.1016/S0140-6736(24)01027-4..
- ClinicalTrials.gov. National Library of Medicine (U.S.).
Open-label Multi-site Extension Trial in Subjects Who Completed the
DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841
https://clinicaltrials.gov/ct2/show/NCT04949841.
- Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment
of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin
Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag.
2021 Mar 18;17:233.
- Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and
emerging therapies for hand eczema. Dermatol Ther.
2019;32(3):e12840.
- Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for
diagnosis, prevention, and treatment of hand eczema. Contact
Dermatitis. 2022;86(5):357-378.
- Grant L, Seiding Larsen L, Burrows K, et al. Development of a
Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative
Interviews with Patients and Expert Dermatologists. Adv Ther.
2020;37(2):692-706.
- Thyssen JP, Silverberg JI, Guttman-Yassky E. Chronic hand
eczema understanding has ramifications on clinical management. J
Eur Acad Dermatol Venereol. 2020;34(8):e429-e430.
- Schliemann S, et al. Efficacy and safety of delgocitinib cream
in adults with moderate to severe chronic hand eczema: results of
the Phase 3 DELTA 2 trial. Presented at the European Academy of
Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany.
11– 14 October. Poster Presentation #P0395.
- Bissonnette R, et al. Efficacy and safety of delgocitinib cream
in adults with moderate to severe chronic hand eczema: results of
the Phase 3 DELTA 1 trial. Presented at the European Academy of
Dermatology and Venereology (EADV) Congress 2023. Berlin, Germany.
11– 14 October. Poster Presentation #P0369.
- Gooderham M, et al. Long-term safety and efficacy of
delgocitinib cream for up to 36 weeks in adults with Chronic Hand
Eczema: results of the Phase 3 open-label extension DELTA-3 trial.
Presented at the 2024 American Academy of Dermatology Annual
Meeting; March 8-12 2024; San Diego, CAx
- Lynde C, Guenther L, Diepgen TL, et al. Canadian hand
dermatitis management guidelines. J Cutan Med Surg.
2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011
Nov-Dec;15(6):360.
- Diepgen TL, et al. Guidelines for diagnosis, prevention and
treatment of hand eczema. J Dtsch Dermatol Ges. 2015
Jan;13(1):e1–22.
- Bissonnette R, et al. Redefining treatment options in chronic
hand eczema (CHE). JEADV. 2010;24;1–20.
- Thyssen, et al. The epidemiology of hand eczema in the general
population – prevalence and main findings. Contact Dermatitis.
2010;62:75-87.
- Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of
life in patients with severe chronic hand eczema refractory to
standard therapy with topical potent corticosteroids. Contact
Dermatitis. 2014;70(3):158-168.
- Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity
of Hand Eczema in the Dutch General Population: A Cross-sectional,
Questionnaire Study within the Lifelines Cohort Study. Acta Derm
Venereol. 2022;102:adv00626.
MAT-75246 July 2024
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Jes Broe Frederiksen Global Commercial Communication +45 53 60
59 48 JEBFE@leo-pharma.com
Jeppe Ilkjær Global Corporate Communications +45 3050 2014
JEILK@leo-pharma.com