Cibinqo

abrocitinib

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Patient safety

Overview

Cibinqo is a medicine used to treat adults with moderate to severe atopic dermatitis (also known as eczema, when the skin is itchy, red and dry). It is used in patients for whom treatment applied directly to the skin cannot be used or is not sufficient.

Cibinqo contains the active substance abrocitinib.

: Cibinqo can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with atopic dermatitis.
The medicine is available as tablets to be taken by mouth once a day. Your doctor may interrupt treatment if certain side effects occur, including serious infections. Your doctor may also stop treatment with Cibinqo if symptoms do not improve after 24 weeks of treatment.
For more information about using Cibinqo, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Cibinqo, abrocitinib, works by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation that occurs in atopic dermatitis. By blocking the enzymes’ action, abrocitinib helps reduce itching and inflammation of the skin.

: Cibinqo was effective at reducing the extent and severity of atopic dermatitis in three main studies involving patients with moderate to severe disease that had not responded well enough to treatment applied to the skin. The main measures of effectiveness were having clear or almost clear skin and a reduced symptom score of at least 75% after 12 weeks.
The first study involved 387 adults and children aged 12 years and above. Around 44% of patients taking 200 mg Cibinqo had clear or almost clear skin, compared with 8% of those who received placebo (a dummy treatment). In addition, symptoms were satisfactorily reduced in 63% of patients who received 200 mg Cibinqo, compared with around 12% of those who received placebo.
In the second study, involving 391 adults and children aged 12 years and above, treatment with 200 mg Cibinqo led to clear or almost clear skin in about 38% of the patients compared with around 9% of patients receiving placebo. Symptoms were satisfactorily reduced in 61% of patients taking 200 mg Cibinqo, compared with 10% of those receiving placebo.
In the third study, involving 838 adult patients, treatment with 200 mg Cibinqo led to clear or almost clear skin in around 48% of patients compared with 14% of those receiving placebo. Symptoms were satisfactorily reduced in 70% of patients taking 200 mg Cibinqo, compared with about 27% of patients on placebo.

: For the complete list of side effects and restrictions with Cibinqo, see the package leaflet.
The most common side effect with Cibinqo (which may affect more than 1 in 10 people) is nausea (feeling sick). Other common side effects (which may affect up to 1 in 100 people) include headache, acne, herpes simplex (viral infection of the mouth or the genitals), increased levels of creatine phosphokinase in the blood (an enzyme released into the blood when muscle is damaged), vomiting, dizziness and pain in the upper belly. The most common serious side effect is infection.
Cibinqo must not be used in patients who are hypersensitive (allergic) to any of the ingredients, in patients with a serious generalized infection, including tuberculosis, or in patients with severe liver problems. The medicine must also not be used during pregnancy or breast-feeding. Women who are able to have children must use contraception during treatment with Cibinqo and for one month after stopping treatment.
Cibinqo should only be used if no suitable treatment alternatives are available in patients aged 65 years or above, in patients with a history of cardiovascular disease (such as heart attack or stroke) or with risk factors for such a disease (such as current or previous long-term smokers), or in patients at increased risk of cancer.

: The European Medicines Agency decided that Cibinqo’s benefits are greater than its risks and it can only be authorised for use in adults in the EU.
Three main studies have shown that Cibinqo is effective at clearing the skin and reducing symptoms of atopic dermatitis. The side effects are considered manageable for adults. Due to findings in the bones of juvenile rats, additional long-term data in growing adolescents are needed to conclude that Cibinqo can be safely used by this age group.

: The company that markets Cibinqo will provide educational materials for doctors prescribing the medicine and an alert card for patients, containing important information about the risks associated with the medicine. Particularly the risks of infections, thrombosis (formation of blood clots in the blood vessels), major cardiovascular events and cancer in certain patients. They will also include a reminder that Cibinqo should not be taken during pregnancy and that women who are able to have children should use contraception during treatment and for one month after stopping treatment.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cibinqo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Cibinqo are continuously monitored. Suspected side effects reported with Cibinqo are carefully evaluated and any necessary action taken to protect patients.

: Cibinqo received a marketing authorisation valid throughout the EU on 9 December 2021.

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Cibinqo : EPAR - Medicine overview (PDF/124.69 KB)

First published: 17/12/2021
Last updated: 14/06/2023
EMA/156457/2023
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  (PDF/148.2 KB)
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  (PDF/126.43 KB)
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  (PDF/146.05 KB)
- Italian
  (PDF/121.39 KB)
- Latvian
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- Lithuanian
  (PDF/147.32 KB)
- Maltese
  (PDF/149.38 KB)
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  (PDF/149.17 KB)
- Portuguese
  (PDF/123.46 KB)
- Romanian
  (PDF/145.46 KB)
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  (PDF/146.85 KB)
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  (PDF/144.23 KB)
- Spanish
  (PDF/123.41 KB)
- Swedish
  (PDF/121.99 KB)
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Cibinqo : EPAR - Risk-management-plan summary (PDF/185.42 KB)

First published: 17/12/2021
Last updated: 14/06/2023

This EPAR was last updated on 30/06/2023

Authorisation details

Product details
Name	Cibinqo
Agency product number	EMEA/H/C/005452
Active substance	Abrocitinib
International non-proprietary name (INN) or common name	abrocitinib
Therapeutic area (MeSH)	Dermatitis, Atopic
Anatomical therapeutic chemical (ATC) code	D11AH08
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.

Publication details
Marketing-authorisation holder	Pfizer Europe MA EEIG
Revision	5
Date of issue of marketing authorisation valid throughout the European Union	09/12/2021
Contact address	Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium

Product information

28/06/2023 Cibinqo - EMEA/H/C/005452 - IB/0011

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Cibinqo : EPAR - Product information (PDF/483.16 KB)

First published: 17/12/2021
Last updated: 30/06/2023
- Bulgarian
  (PDF/506.01 KB)
- Croatian
  (PDF/374.3 KB)
- Czech
  (PDF/388.92 KB)
- Danish
  (PDF/355.7 KB)
- Dutch
  (PDF/382.2 KB)
- Estonian
  (PDF/746.5 KB)
- Finnish
  (PDF/388.12 KB)
- French
  (PDF/531.76 KB)
- German
  (PDF/681.43 KB)
- Greek
  (PDF/391.83 KB)
- Hungarian
  (PDF/547.5 KB)
- Icelandic
  (PDF/507.25 KB)
- Italian
  (PDF/689.26 KB)
- Latvian
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- Lithuanian
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- Maltese
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- Norwegian
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- Polish
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- Portuguese
  (PDF/375.08 KB)
- Romanian
  (PDF/435.11 KB)
- Slovak
  (PDF/384.09 KB)
- Slovenian
  (PDF/365.06 KB)
- Spanish
  (PDF/369.45 KB)
- Swedish
  (PDF/725.21 KB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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Cibinqo : EPAR - All authorised presentations (PDF/38.28 KB)

First published: 17/12/2021
- Bulgarian
  (PDF/36.48 KB)
- Croatian
  (PDF/34.14 KB)
- Czech
  (PDF/34.87 KB)
- Danish
  (PDF/35.5 KB)
- Dutch
  (PDF/34.36 KB)
- Estonian
  (PDF/34 KB)
- Finnish
  (PDF/34.95 KB)
- French
  (PDF/33.59 KB)
- German
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- Greek
  (PDF/37.26 KB)
- Hungarian
  (PDF/35.72 KB)
- Icelandic
  (PDF/35.09 KB)
- Italian
  (PDF/34.7 KB)
- Latvian
  (PDF/34.88 KB)
- Lithuanian
  (PDF/36.13 KB)
- Maltese
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- Norwegian
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- Polish
  (PDF/34.46 KB)
- Portuguese
  (PDF/39.5 KB)
- Romanian
  (PDF/35.61 KB)
- Slovak
  (PDF/35.93 KB)
- Slovenian
  (PDF/34.68 KB)
- Spanish
  (PDF/34.38 KB)
- Swedish
  (PDF/34.47 KB)

Pharmacotherapeutic group

Other dermatological preparations

Therapeutic indication

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Assessment history

Changes since initial authorisation of medicine

List item

Cibinqo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/140.13 KB)

First published: 23/08/2022
Last updated: 30/06/2023
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Cibinqo-H-A20-1517-C-005452-0003 : EPAR - Assessment Report (PDF/751.5 KB)

Adopted

First published: 14/06/2023
EMA/586384/2022
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Cibinqo : EPAR - Scientific conclusions for Article 20 referral - Divergent positions of CHMP (PDF/126.74 KB)

First published: 14/06/2023
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Cibinqo : EPAR - Scientific conclusions for Article 20 referral (Annex IV) (PDF/139.86 KB)

First published: 14/06/2023
- Bulgarian
  (PDF/203.66 KB)
- Croatian
  (PDF/208.34 KB)
- Czech
  (PDF/217.54 KB)
- Danish
  (PDF/182.81 KB)
- Dutch
  (PDF/185.49 KB)
- Estonian
  (PDF/172.43 KB)
- Finnish
  (PDF/169.26 KB)
- French
  (PDF/178.06 KB)
- German
  (PDF/192.42 KB)
- Greek
  (PDF/202.37 KB)
- Hungarian
  (PDF/215.29 KB)
- Icelandic
  (PDF/189.22 KB)
- Italian
  (PDF/180.64 KB)
- Latvian
  (PDF/202.23 KB)
- Lithuanian
  (PDF/225.26 KB)
- Maltese
  (PDF/226.94 KB)
- Norwegian
  (PDF/180 KB)
- Polish
  (PDF/211.18 KB)
- Portuguese
  (PDF/181.57 KB)
- Romanian
  (PDF/221.05 KB)
- Slovak
  (PDF/199.58 KB)
- Slovenian
  (PDF/222.12 KB)
- Spanish
  (PDF/180.84 KB)
- Swedish
  (PDF/182.3 KB)

Initial marketing-authorisation documents

Patient Safety

EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders

28/10/2022

Cibinqo

Table of contents

Overview

Cibinqo : EPAR - Medicine overview (PDF/124.69 KB)

Cibinqo : EPAR - Risk-management-plan summary (PDF/185.42 KB)

Authorisation details

Product information

Cibinqo : EPAR - Product information (PDF/483.16 KB)

Cibinqo : EPAR - All authorised presentations (PDF/38.28 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Cibinqo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/140.13 KB)

Cibinqo-H-A20-1517-C-005452-0003 : EPAR - Assessment Report (PDF/751.5 KB)

Cibinqo : EPAR - Scientific conclusions for Article 20 referral - Divergent positions of CHMP (PDF/126.74 KB)

Cibinqo : EPAR - Scientific conclusions for Article 20 referral (Annex IV) (PDF/139.86 KB)

Initial marketing-authorisation documents

Cibinqo : EPAR - Public assessment report (PDF/7.96 MB)

CHMP summary of opinion for Cibinqo (PDF/126.14 KB)

Patient Safety

News

Direct healthcare professional communications (DHPC)

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