Anzupgo
Authorised
This medicine is authorised for use in the European Union
delgocitinib
MedicineHumanAuthorised
- 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.
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.
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 in chronic hand eczema. Delgocitinib helps reduce the inflammation and other symptoms of the condition.
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.
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.
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.
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.
Anzupgo received a marketing authorisation valid throughout the EU on 19 September 2024.
Product information
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).
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 preparationsTherapeutic indication
Anzupgo is indicated for the treatment of moderate to severe chronic hand eczema (CHE)
News on Anzupgo
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