Icotyde
Authorised
This medicine is authorised for use in the European Union
icotrokinra hydrochloride
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Icotyde is a medicine for treating moderate-to-severe plaque psoriasis (a disease causing red, scaly patches on the skin).
It is used in adults who need systemic (whole-body) treatment and in adolescents from 12 years of age weighing at least 40 kg who need such treatment.
Icotyde contains the active substance icotrokinra.
Treatment should be started under the guidance and supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Icotyde is available as a tablet taken by mouth once a day, after waking, on an empty stomach. Patients should not eat for at least 30 minutes after taking the tablet. If treatment has not worked well enough after 24 weeks, the doctor may consider stopping treatment.
The medicine can only be obtained with a prescription. For more information about using Icotyde, see the package leaflet or contact your doctor or pharmacist.
The active substance in Icotyde, icotrokinra, works by blocking the receptor for interleukin-23, a protein that plays a role in the inflammation seen in plaque psoriasis. By blocking the action of interleukin-23, icotrokinra reduces inflammation and symptoms associated with the disease.
Four main studies involving around 2,500 patients from 12 years of age with moderate-to-severe plaque psoriasis showed that Icotyde was effective at treating psoriasis lesions.
In three of these studies, after 16 weeks, between 50% and 57% of patients who took Icotyde achieved PASI 90 (a 90% or more drop in a measure of how severe and widespread the skin lesions are), compared with between 1% and 4% of patients who took placebo (a dummy treatment). In addition, between 65% and 71% of patients who took Icotyde achieved an IGA score of 0 or 1, meaning their skin was clear or almost clear of psoriasis lesions, compared with 8% to 11% of those who took placebo.
A fourth study involved patients with psoriasis affecting difficult-to-treat areas such as the scalp, genital region, hands and feet.
Studies carried out with Icotyde are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Icotyde, see the package leaflet.
The most common side effect with Icotyde (which may affect around 1 in 100 people) is fungal infections.
Icotyde must not be used in people with important active infections (such as active tuberculosis).
Studies have shown that Icotyde is effective at clearing plaque psoriasis lesions, with most patients having clear or almost clear skin after treatment. The medicine was effective in different groups of patients and over time. It was generally well tolerated, causing few side effects, which were considered manageable.
The European Medicines Agency therefore decided that Icotyde’s benefits are greater than its risks and that 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 Icotyde have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Icotyde are continuously monitored. Suspected side effects reported with Icotyde are carefully evaluated and any necessary action is taken to protect patients.
Icotyde received a marketing authorisation valid throughout the EU on 18 September 2026.
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
- Icotyde
- Active substance
- icotrokinra hydrochloride
- International non-proprietary name (INN) or common name
- icotrokinra hydrochloride
- Therapeutic area (MeSH)
- Psoriasis
- Anatomical therapeutic chemical (ATC) code
- L04AC28
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Icotyde is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy
News on Icotyde
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