Human medicines European public assessment report (EPAR): Sotyktu, deucravacitinib, Date of authorisation: 24/03/2023, Revision: 5, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Sotyktu is a medicine for treating adults with moderate to severe plaque psoriasis (an inflammatory disease causing red, scaly patches on the skin) who are eligible for systemic therapy (treatment with a medicine given by mouth or by injection).

Sotyktu is also used for treating adults with psoriatic arthritis (inflammation of the joints associated with psoriasis) who could not take, or whose condition had not improved enough with, other treatments called disease-modifying anti-rheumatic drugs (DMARDs). It may be used on its own or together with methotrexate.

Sotyktu contains the active substance deucravacitinib.

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How is Sotyktu used?

Sotyktu can only be obtained with a prescription. Treatment should be started by a doctor experienced in the diagnosis and treatment of the conditions for which Sotyktu is used.

Sotyktu is available as tablets to be taken once a day. The doctor should evaluate the effect of the treatment regularly and may stop treatment if the condition does not improve after 24 weeks.

For more information about using Sotyktu, including dose recommendations, see the package leaflet or contact your doctor or pharmacist.

How does Sotyktu work?

The active substance in Sotyktu, deucravacitinib, blocks the action of an enzyme inside cells called tyrosine kinase 2 (TYK2) which belongs to the Janus kinases (JAK) family of proteins. This enzyme plays a role in triggering the production of substances known as cytokines, which are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis. By blocking the action of TYK2, deucravacitinib prevents the production of cytokines, thereby reducing inflammation and improving the symptoms of these conditions.

What benefits of Sotyktu have been shown in studies?

Plaque psoriasis

Two main studies involving 1,686 adults with moderate to severe plaque psoriasis compared Sotyktu with placebo (a dummy treatment) and apremilast, another systemic therapy for plaque psoriasis. The studies looked at an improvement of patients’ symptoms after 16 weeks of treatment.

Around 55% of patients treated with Sotyktu had a reduction of at least 75% in their PASI score (a measure of the severity and extent of skin lesions) compared with around 38% of those treated with apremilast and around 11% of those who received placebo.

Additionally, around 51% of patients treated with Sotyktu achieved a sPGA score (a measure of the severity and extent of skin lesions) of 0 or 1 (where 0 and 1 refer to skin clear or almost clear, respectively) and had a reduction of 2 points or more in their sPGA score. Around 33% of those treated with apremilast and around 8% in those who received placebo had these results.

Improvement of symptoms were maintained after 52 weeks of treatment with Sotyktu.

Psoriatic arthritis

Sotyktu was compared with placebo in two main studies involving a total of 1,458 adults with psoriatic arthritis who could not take, or whose condition had not improved enough with, a DMARD. In both studies, the main measure of effectiveness was the number of people who had at least a 20% improvement in signs and symptoms of the disease (ACR20) after 16 weeks of treatment. In the first study, around 54% of people taking Sotyktu achieved ACR20, compared with around 34% of those taking placebo. In the second study, around 54% of people taking Sotyktu achieved ACR20, compared with around 39% of those given placebo.

Symptoms continued to improve after 16 weeks of treatment with Sotyktu, and results were maintained for up to 52 weeks.

Studies carried out with Sotyktu are described in more detail in the medicine’s assessment reports.

What are the side effects and restrictions with Sotyktu?

For the full list of side effects and restrictions with Sotyktu, see the package leaflet.

The most common side effect with Sotyktu (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection).

Patients who have an important or long-term infection, or an infection that keeps coming back, must not take this medicine.

Why is Sotyktu authorised in the EU?

Sotyktu was shown to be effective at reducing symptoms of moderate to severe plaque psoriasis. Sotyktu provides an additional treatment option for patients with plaque psoriasis who have not yet been treated with systemic therapy and those who do not benefit from other systemic therapies. Sotyktu was also shown to be effective at treating psoriatic arthritis in adults who could not take, or whose condition had not improved enough with a prior DMARD.

Side effects are mild to moderate and manageable.

Therefore, the European Medicines Agency decided that Sotyktu’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Sotyktu?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sotyktu have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Sotyktu are continuously monitored. Suspected side effects reported with Sotyktu are carefully evaluated and any necessary action taken to protect patients.

Other information about Sotyktu

Sotyktu received a marketing authorisation valid throughout the EU on 24 March 2023.

Sotyktu : EPAR - Medicine overview

Adopted

Reference Number:

EMADOC-1829012207-47869

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Sotyktu : EPAR - Risk Management Plan

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Product information

Sotyktu : EPAR - Product information

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Latest procedure affecting product information:

VR/0000282554

30/04/2026

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).

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Product details

Name of medicine

Sotyktu

Active substance

deucravacitinib

International non-proprietary name (INN) or common name

deucravacitinib

Therapeutic area (MeSH)

Psoriasis

Anatomical therapeutic chemical (ATC) code

L04AF07

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Plaque psoriasis Sotyktu is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Psoriatic arthritis Sotyktu, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy.

Authorisation details

EMA product number

EMEA/H/C/005755

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

Bristol-Myers Squibb Pharma EEIG

Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland

Opinion adopted

26/01/2023

Marketing authorisation issued

24/03/2023

Revision

5

Assessment history

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Changes since initial authorisation of medicine

Sotyktu : EPAR - Procedural steps taken and scientific information after authorisation

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12/05/2026

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Sotyktu : EPAR - Procedural steps taken and scientific information after authorisation (archive)

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First published:

21/12/2023

Last updated:

12/05/2026

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Sotyktu-VR-0000282554 : EPAR - Assessment report - Variation

Adopted

Reference Number:

EMADOC-1700519818-2802677

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12/05/2026

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CHMP post-authorisation summary of positive opinion for Sotyktu (VR/0000282554)

Adopted

Reference Number:

EMADOC-1700519818-2802747

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First published:

27/03/2026

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Initial marketing authorisation documents

Sotyktu : EPAR - Public Assessment Report

Adopted

Reference Number:

EMA/68815/2023

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31/03/2023

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CHMP summary of positive opinion for Sotyktu

Adopted

Reference Number:

EMA/CHMP/898000/2023

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First published:

27/01/2023

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News on Sotyktu

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026

27/03/2026

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023

27/01/2023

More information on Sotyktu

• EMEA-002350-PIP01-18-M03 - paediatric investigation plan
• EMEA-002350-PIP02-20-M01 - paediatric investigation plan
• EMEA-002350-PIP05-23 - paediatric investigation plan
• Long-term, observational cohort study of adults with plaque psoriasis (PsO), who are new users of deucravacitinib, tumour necrosis factor inhibitor (TNFi) biologics, non-TNFi biologics, or non-biologic therapies in the real-world clinical setting - post-authorisation study

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