Human medicines European public assessment report (EPAR): Anzupgo, delgocitinib, Date of authorisation: 19/09/2024, Revision: 3, Status: Authorised
Human medicines European public assessment report (EPAR): Anzupgo, delgocitinib, Date of authorisation: 19/09/2024, Revision: 3, Status: Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Anzupgo is used to treat moderate to severe chronic hand eczema (a long-term condition where the skin of the hands is itchy, red and dry) in adults who cannot use corticosteroids applied to the skin or in whom such corticosteroids do not work well enough.
Anzupgo contains the active substance delgocitinib.
Expand section
Collapse section
How is Anzupgo used?
Anzupgo can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of chronic hand eczema.
Anzupgo is available as a cream, that is applied as a thin layer to affected skin of the hands and wrists twice a day. The cream should be applied at regular intervals and treatment should be continued until symptoms improve or disappear, after which it can be stopped. If symptoms recur, treatment can be re-started as needed. If no improvement is seen after 12 weeks of continuous treatment, treatment should be stopped.
For more information about using Anzupgo, see the package leaflet or contact your doctor or pharmacist.
How does Anzupgo work?
The active substance in Anzupgo, delgocitinib, works by blocking the action of enzymes (proteins) known as Janus kinases. These enzymes play an important role in the process of inflammation that occurs inchronic hand eczema. Delgocitinib helps reduce the inflammation and other symptoms of the condition.
What benefits of Anzupgo have been shown in studies?
Anzupgo was more effective than a placebo (dummy) cream at reducing the extent and severity of symptoms in two main studies involving 960 adults with moderate to severe chronic hand eczema. In both studies, the main measure of effectiveness was the proportion of patients who achieved a score of 0 (clear) or 1 (almost clear) on a 5-point scale for chronic hand eczema (the IGA-CHE scale), with an improvement of at least 2 points after 16 weeks of treatment.
The results showed that most, or all, of the chronic hand eczema had cleared up in around 20% of patients treated with Anzupgo in the first study compared with around 10% of patients using placebo. In the second study, these figures were around 29% for patients treated with Anzupgo and around 7% for patients using placebo.
What are the risks associated with Anzupgo?
For the full list of side effects and restrictions with Anzupgo, see the package leaflet.
The most common side effects with Anzupgo (which may affect 1 in 100 people) include application site reactions such as itching, redness, pain and a burning or prickling sensation.
Why is Anzupgo authorised in the EU?
Anzupgo reduces the extent and severity of chronic hand eczema in adults with moderate to severe disease who cannot use corticosteroids that are applied to the skin or in whom such corticosteroids do not work well enough. At the time of approval of Anzupgo, treatment options for these patients were very limited.
Regarding safety, Anzupgo‘s side effects are generally mild and manageable. The European Medicines Agency therefore decided that Anzupgo’s benefits are greater than its risks and it can be authorised in the EU.
What measures are being taken to ensure the safe and effective use of Anzupgo?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anzupgo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Anzupgo are continuously monitored. Suspected side effects reported with Anzupgo are carefully evaluated and any necessary action taken to protect patients.
Other information about Anzupgo
Anzupgo received a marketing authorisation valid throughout the EU on 19 September 2024.
Anzupgo : EPAR - Medicine overview
Reference Number:
EMA/355342/2024
English (EN) (115.37 KB - PDF)
First published:
24/09/2024
View
Other languages (22)
български (BG) (138.08 KB - PDF)
First published:
24/09/2024
View
español (ES) (114.49 KB - PDF)
First published:
24/09/2024
View
čeština (CS) (135.39 KB - PDF)
First published:
24/09/2024
View
dansk (DA) (123.57 KB - PDF)
First published:
24/09/2024
View
Deutsch (DE) (116.8 KB - PDF)
First published:
24/09/2024
View
eesti (ET) (112.95 KB - PDF)
First published:
24/09/2024
View
ελληνικά (EL) (138 KB - PDF)
First published:
24/09/2024
View
français (FR) (115.53 KB - PDF)
First published:
24/09/2024
View
hrvatski (HR) (134.63 KB - PDF)
First published:
24/09/2024
View
italiano (IT) (113.67 KB - PDF)
First published:
24/09/2024
View
latviešu (LV) (154.76 KB - PDF)
First published:
24/09/2024
View
lietuvių (LT) (135.09 KB - PDF)
First published:
24/09/2024
View
magyar (HU) (133.51 KB - PDF)
First published:
24/09/2024
View
Malti (MT) (146.5 KB - PDF)
First published:
24/09/2024
View
Nederlands (NL) (114.5 KB - PDF)
First published:
24/09/2024
View
polski (PL) (136.45 KB - PDF)
First published:
24/09/2024
View
português (PT) (115.86 KB - PDF)
First published:
24/09/2024
View
română (RO) (134.16 KB - PDF)
First published:
24/09/2024
View
slovenčina (SK) (135.97 KB - PDF)
First published:
24/09/2024
View
slovenščina (SL) (134.64 KB - PDF)
First published:
24/09/2024
View
suomi (FI) (112.99 KB - PDF)
First published:
24/09/2024
View
svenska (SV) (114.13 KB - PDF)
First published:
24/09/2024
View
Anzupgo : EPAR - Risk management plan
English (EN) (792.22 KB - PDF)
First published:
24/09/2024
View
Product information
Anzupgo : EPAR - Product information
English (EN) (423.95 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Other languages (24)
български (BG) (470.21 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
español (ES) (431.82 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
čeština (CS) (459.99 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
dansk (DA) (425.59 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Deutsch (DE) (447.18 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
eesti (ET) (433.65 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
ελληνικά (EL) (502.57 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
français (FR) (438.34 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
hrvatski (HR) (463.13 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
italiano (IT) (422.45 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
latviešu (LV) (448.4 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
lietuvių (LT) (470.65 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
magyar (HU) (477.74 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Malti (MT) (479.65 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Nederlands (NL) (432.71 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
polski (PL) (477.15 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
português (PT) (425.45 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
română (RO) (496.05 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
slovenčina (SK) (479.81 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
slovenščina (SL) (475.77 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
suomi (FI) (428.73 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
svenska (SV) (420.61 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Íslenska (IS) (446.65 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
norsk (NO) (417.75 KB - PDF)
First published:
24/09/2024
Last updated:
08/12/2025
View
Latest procedure affecting product information:
VR/0000264200
23/10/2025
This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Anzupgo : EPAR - All authorised presentations
English (EN) (47.31 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Other languages (24)
български (BG) (65.23 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
español (ES) (47.98 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
čeština (CS) (64.98 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
dansk (DA) (48.85 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Deutsch (DE) (49.73 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
eesti (ET) (46.99 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
ελληνικά (EL) (64.76 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
français (FR) (47.32 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
hrvatski (HR) (64.35 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
italiano (IT) (47.76 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
latviešu (LV) (64.83 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
lietuvių (LT) (68.61 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
magyar (HU) (67.53 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Malti (MT) (64.14 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Nederlands (NL) (47.25 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
polski (PL) (64.95 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
português (PT) (45.52 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
română (RO) (64.34 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
slovenčina (SK) (66.45 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
slovenščina (SL) (55.11 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
suomi (FI) (47.24 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
svenska (SV) (44.81 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Íslenska (IS) (48.83 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
norsk (NO) (48.54 KB - PDF)
First published:
24/09/2024
Last updated:
18/06/2025
View
Product details
Name of medicine
Anzupgo
Active substance
Delgocitinib
International non-proprietary name (INN) or common name
delgocitinib
Therapeutic area (MeSH)
- Dermatitis
- Eczema
Anatomical therapeutic chemical (ATC) code
D11AH11
Pharmacotherapeutic group
Other dermatological preparations
Therapeutic indication
Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE)
Authorisation details
EMA product number
EMEA/H/C/006109
Additional monitoring
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Marketing authorisation holder
LEO Pharma A/S
Industriparken 55 DK-2750 Ballerup Denmark
Opinion adopted
25/07/2024
Marketing authorisation issued
19/09/2024
Revision
3
Assessment history
Expand section
Collapse section
Changes since initial authorisation of medicine
Anzupgo : EPAR - Procedural steps taken and scientific information (archive)
English (EN) (143.2 KB - PDF)
First published:
09/12/2025
View
Anzupgo : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (152.9 KB - PDF)
First published:
18/06/2025
Last updated:
08/12/2025
View
Anzupgo-PAM-0000335934 : EPAR - Assessment report
Adopted
Reference Number:
EMADOC-1700519818-3257335
English (EN) (338.74 KB - PDF)
First published:
17/07/2026
View
Anzupgo-PAM-0000280076 : EPAR - Assessment report - Variation
Reference Number:
EMADOC-1700519818-2222735
English (EN) (490.82 KB - PDF)
First published:
06/10/2025
View
Initial marketing authorisation documents
Anzupgo : EPAR - Public assessment report
Adopted
Reference Number:
EMA/372390/2024
English (EN) (7.47 MB - PDF)
First published:
24/09/2024
View
CHMP summary of positive opinion for Anzupgo
Adopted
Reference Number:
EMA/CHMP/239042/2024
English (EN) (157.54 KB - PDF)
First published:
26/07/2024
View
News on Anzupgo
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
26/07/2024
More information on Anzupgo
This page was last updated on
17/07/2026
Summary
Anzupgo is used to treat moderate to severe chronic hand eczema (a long-term condition where the skin of the hands is itchy, red and dry) in adults who cannot use corticosteroids applied to the skin or in whom such corticosteroids do not work well enough. Anzupgo contains the active substance delgocitinib.