Opzelura

Authorised

This medicine is authorised for use in the European Union

ruxolitinib

Overview

Opzelura is a medicine used for treating:

• non-segmental vitiligo, a disease that causes patches of skin to lose colour on both sides of the body. In patients with vitiligo, the immune system (the body’s natural defences) attacks melanocytes (the skin cells that make pigment), causing patches of pale pink or white skin (depigmentation). Opzelura is used in adults and adolescents from 12 years of age with non-segmental vitiligo that also affects the face;
• moderate atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry) in adults when topical treatment (treatment applied to the skin) with corticosteroids and calcineurin inhibitors are not sufficient or appropriate.

Opzelura contains the active substance ruxolitinib.

How is Opzelura used?

Opzelura can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in the diagnosis and treatment of the conditions Opzelura is used to treat. Opzelura is available as a cream.

For the treatment of vitiligo, Opzelura should be applied to the depigmented skin twice a day. Opzelura should not be applied to more than 10% of the body at the same time.

Treatment may be needed for more than 6 months to obtain satisfactory repigmentation of the skin (return of skin colour). The doctor may stop treatment if there is no satisfactory improvement after one year of treatment.

For the treatment of atopic dermatitis, Opzelura should be applied to the affected skin area twice a day. Opzelura should not be applied to more than 20% of the body at the same time. If there is no satisfactory improvement after 8 weeks of treatment, the doctor may stop treatment.

For both vitiligo and atopic dermatitis, treatment can be restarted if symptoms return.

For more information about using Opzelura, see the package leaflet or contact your doctor or pharmacist.

How does Opzelura work?

The active substance in Opzelura, ruxolitinib, works by blocking enzymes known as Janus kinase (JAK) 1 and 2, which are involved in the activity of a substance called interferon gamma (IFN-gamma).  

In vitiligo, IFN-gamma is thought to play a role in the activity of the cells of the immune system that attack melanocytes. By blocking JAK1 and JAK2, ruxolitinib reduces the immune system’s ability to destroy melanocytes, allowing them to produce pigment. 

Janus kinase enzymes are also involved in processes in the body that cause inflammation and itching. By blocking JAK1 and JAK2, ruxolitinib helps to control the symptoms of atopic dermatitis. 

What benefits of Opzelura have been shown in studies?

Vitiligo 

In 2 main studies, Opzelura was shown to improve repigmentation compared with placebo (dummy treatment). 

The main measure of effectiveness was the proportion of patients who achieved an improvement of at least 75% in the pigmentation of their face as measured using a standard score for facial vitiligo (F-VASI75) after 6 months.  

The 2 studies involved a total of 661 patients with non-segmental vitiligo. On average, around 31% of patients who received Opzelura achieved an improvement of at least 75% in the pigmentation of their face after 6 months of treatment, compared with around 10% of those who received placebo. Using a standard score for total body pigmentation (T-VASI50), the studies further showed that, after 6 months, total body pigmentation improved by at least 50% in 22% of patients who used Opzelura compared with 6% of those receiving placebo. 

Atopic dermatitis 

One main study involving 241 adults with moderate atopic dermatitis for whom topical corticosteroids or calcineurin inhibitors were not suitable or had not worked well enough found that Opzelura is more effective than a placebo (dummy) cream. 

Improvements were measured using the Eczema Area and Severity Index (EASI) to see how many patients had a 75% improvement or more in their clinical symptoms across different parts of the body (also known as EASI-75). The Investigator’s Global Assessment (IGA) scale (where 0 indicates clear skin and 4 indicates severe disease) was also used to measure treatment success, based on an IGA score of 0 or 1 and an overall improvement of at least 2 points.The results showed that, after 8 weeks, 70% of patients using Opzelura achieved an EASI-75 compared with around 19% of those using the placebo cream. In addition, around 61% of people who used Opzelura achieved IGA treatment success compared with around 14% of those using placebo. 

Supportive data also showed that Opzelura improved symptoms of itching, with around 63% of people using Opzelura reporting an improvement in itch symptoms after 8 weeks compared with around 20% of those using the placebo cream, based on scores measured on a standard itch scale. Patients also reported improvements in how much their skin problem affected their daily life and in sleep disturbance. 

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

What are the side effects and restrictions with Opzelura?

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

The most common side effect with Opzelura (which may affect up to 1 in 10 people) is acne at the site where the medicine was applied. 

Women who are pregnant or breastfeeding must not use Opzelura. 

Why is Opzelura authorised in the EU?

Opzelura has been shown to have beneficial effects on the repigmentation of the skin in patients with non-segmental vitiligo. It is also effective in treating adults with moderate atopic dermatitis for whom available topical treatments are not suitable or do not work well enough.  

In terms of safety, the side effects of Opzelura are considered acceptable. While ruxolitinib medicines taken by mouth are associated with serious side effects, these effects are not expected to occur with Opzelura since it is used as a cream, provided that it is not used on more than 10% of the body in one application when used to treat non-segmental vitiligo, and 20% of the body when used to treat atopic dermatitis. 

The European Medicines Agency therefore decided that Opzelura’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 Opzelura?

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

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

Other information about Opzelura

Opzelura received a marketing authorisation valid throughout the EU on 19 April 2023.

Opzelura : EPAR - Medicine overview

Reference Number: EMADOC-1829012207-57982

Opzelura : EPAR - Risk management plan

Product information

Opzelura : EPAR - Product Information

Opzelura : EPAR - All Authorised Presentations

Product details

• Name of medicine:
  Opzelura
• Active substance:
  ruxolitinib phosphate
• International non-proprietary name (INN) or common name:
  ruxolitinib
• Therapeutic area (MeSH):
  • Vitiligo
  • Dermatitis, Atopic
• Anatomical therapeutic chemical (ATC) code:
  D11AH

Pharmacotherapeutic group

Other dermatological preparations

Therapeutic indication

Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Authorisation details

• EMA product number:
  EMEA/H/C/005843
• Marketing authorisation holder:
  Incyte Biosciences Distribution B.V.

  Paasheuvelweg 25; 1105 BP Amsterdam; The Netherlands

• Opinion adopted:
  23/02/2023
• Marketing authorisation issued:
  19/04/2023
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

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

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

Opzelura-VR-0000313318 : EPAR - Assessment report - Variation

Adopted Reference Number: EMADOC-1700519818-3086714

Opzelura-PSUSA-00011052-202509 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMADOC-1700519818-3267049

CHMP post-authorisation summary of positive opinion for Opzelura (VR-0000313318)

Adopted Reference Number: EMADOC-1700519818-3086715

Initial marketing authorisation documents

Opzelura : EPAR - Public Assessment Report

Adopted Reference Number: EMA/135534/2023

CHMP summary of positive opinion for Opzelura

Adopted Reference Number: EMA/CHMP/27927/2023