Uzpruvo
Authorised
This medicine is authorised for use in the European Union
ustekinumab
MedicineHumanAuthorised
Overview
Uzpruvo is a medicine used to treat:
- moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin). It is used in adults and children from 6 years of age whose condition has not improved enough with, or who cannot use, other systemic (whole-body) psoriasis treatments, such as ciclosporin, methotrexate or PUVA (psoralen ultraviolet A). PUVA is a type of treatment where the patient receives a medicine called psoralen, before being exposed to ultraviolet light;
- active psoriatic arthritis (inflammation of the joints associated with psoriasis) in adults, when the condition has not improved enough with other treatments called disease-modifying anti-rheumatic drugs (DMARDs). Uzpruvo may be used alone or combined with methotrexate (a DMARD);
- moderately to severely active Crohn’s disease (a disease-causing inflammation of the gut) in adults whose condition has not improved enough with other treatments for Crohn’s disease or who cannot receive such treatments.
Uzpruvo is a ‘biosimilar medicine’. This means that Uzpruvo is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Uzpruvo is Stelara. For more information on biosimilar medicines, see here.
Uzpruvo contains the active substance ustekinumab.
Uzpruvo can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Uzpruvo is used for.
In plaque psoriasis and psoriatic arthritis, Uzpruvo is injected under the skin using a pre-filled syringe. The first injection is followed by a further injection 4 weeks later, and then an injection every 12 weeks. Because Uzpruvo is only available in pre-filled syringes which inject doses of 45 or 90 mg, children under 60 kg who need lower doses should use another medicine containing the same active substance (ustekinumab) which allows the dose to be adjusted as needed.
In Crohn’s disease, treatment must be started as an infusion (drip) into a vein over at least 1 hour. Because Uzpruvo is only available in pre-filled syringes for injection under the skin, another medicine containing ustekinumab which can be given as an infusion should be used to start treatment. Eight weeks after the infusion with the other medicine, Uzpruvo can then be given as an injection under the skin and patients can continue with Uzpruvo every 8 or 12 weeks depending on how well the treatment is working.
Patients or their caregivers may inject Uzpruvo under the skin once they have been trained, if their doctor thinks that this is appropriate.
For more information about using Uzpruvo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Uzpruvo, ustekinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target in the body. Ustekinumab attaches to 2 messenger molecules in the immune system called interleukin 12 and interleukin 23. Both are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn’s disease. By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Laboratory studies comparing Uzpruvo with Stelara have shown that the active substance in Uzpruvo is highly similar to that in Stelara in terms of structure, purity and biological activity. Studies have also shown that giving Uzpruvo produces similar levels of the active substance in the body to giving Stelara.
In addition, a study involving 581 people with moderate to severe chronic plaque psoriasis showed that Uzpruvo was as effective as Stelara. After 12 weeks of treatment, PASI scores (a measure of disease severity and area of skin affected) had improved by around 87% in both Uzpruvo and Stelara groups.
Because Uzpruvo is a biosimilar medicine, the studies on effectiveness and safety of ustekinumab carried out with Stelara do not all need to be repeated for Uzpruvo.
The safety of Uzpruvo has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Stelara.
For the complete list of side effects and restrictions of Uzpruvo, see the package leaflet.
The most common side effects with Uzpruvo (seen in more than 1 in 20 people) are headache and nasopharyngitis (inflammation of the nose and throat). The most serious side effect reported with Uzpruvo is serious hypersensitivity (allergic reaction).
Uzpruvo must not be used in patients who have an active infection that the doctor considers important.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Uzpruvo has a highly similar structure, purity and biological activity to Stelara and is distributed in the body in the same way. In addition, a study in patients with moderate to severe plaque psoriasis has shown that the safety and effectiveness of Uzpruvo is equivalent to that of Stelara in this indication.
All these data were considered sufficient to conclude that Uzpruvo will behave in the same way as Stelara in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for Stelara, the benefits of Uzpruvo outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Uzpruvo have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Uzpruvo are continuously monitored. Suspected side effects reported with Uzpruvo are carefully evaluated and any necessary action taken to protect patients.
Uzpruvo received a marketing authorisation valid throughout the EU on 5 January 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
- Uzpruvo
- Active substance
- Ustekinumab
- International non-proprietary name (INN) or common name
- ustekinumab
- Therapeutic area (MeSH)
- Psoriasis
- Arthritis, Psoriatic
- Crohn Disease
- Colitis, Ulcerative
- Anatomical therapeutic chemical (ATC) code
- L04AC05
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Plaque psoriasis
Uzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A).
Paediatric plaque psoriasis
Uzpruvo is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Psoriatic arthritis (PsA)
Uzpruvo, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Crohn’s Disease
Uzpruvo is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
News on Uzpruvo
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