Green light for a new vitiligo treatment. L’European Medicines Agency (EMA) authorized on April 19, 2023 the commercialization of Opzelura in Europe (and therefore in France). It’s regarding first specific treatment for vitiligoan autoimmune dermatological pathology which is characterized by a progressive depigmentation of the skin and which would affect nearlyone million people in France. It’s a crème containing ruxolitinib which must be applied in a thin layer on depigmented areas twice a day and that would be particularly effective in treating depigmentation of the face…

What are the indications for Opzelura?

Opzelura is a cream marketed by the Incyte laboratory and indicated for the treatment of vitiligo non-segmental with facial involvement in adults and adolescents from 12 years old. Non-segmental vitiligo (or generalized vitiligo, the most common form of vitiligo) is not limited to just one side of the body, but can affect multiple areas of the body. In this form of vitiligo, “lesions appear in the form of achromic, depigmented plaquesbilateral on the body, sometimes symmetrical“, can we read on the website of the CHU de Bordeaux. Depigmentation can occur on the face, neck, scalp, around the mouth, genitals as well as in areas that tend to undergo rubbing or shocks such as hands or arms.

How does Opzelura work?

Opzelura is a treatment that “anti-HOW“because its mode of action is to block Janus Kinase (JAK) enzymesinvolved in the activity of a substance called interferon-gamma. This substance would play a role in the destruction melanocytes, cells that normally synthesize melanin, the main coloring pigment in the skin. By blocking the action of JAKs, it helps to increase the production of melanocytes and therefore of the skin’s natural pigments. Treatment may be required for more than 6 months (regarding 24 weeks) to achieve satisfactory repigmentation of the skin (return of skin color). The doctor may stop the treatment if there is no satisfactory improvement following one year of treatment.

What does Opzelura contain?

One gram of cream Opzelura contains 15 mg of ruxolitinib (as phosphate). Among its excipients with a notorious effect, we find propylene glycol (E1520), cetyl alcohol, stearyl alcohol or even Butylhydroxytoluene (used as an antioxidant in paraffin).

How effective once morest vitiligo?

The recommended dose is the application of‘a thin layer of cream twice a day on depigmented skin areas (with a maximum of 10% of the body surface) with a minimum of 8 hours between two applications. For information, 10% of the body surface corresponds to an area as large as the equivalent of 10 times the palm of a hand with the 5 fingers. Regarding the efficiencythe Food and Drug Administration – the US Food and Drug Administration – has demonstrated in two clinical trials that 30% of patients under Opzelura (following 6 months of treatment) showed an improvement ofat least 75% of their facial vitiligo ( once morest 10% on placebo). The studies further showed that following 6 months of treatment, total body pigmentation improved by at least 50% in 22% of patients who used Opzelura compared to 6% in those who received placebo.

When will Opzelura be available in France?

Opzelura has already been authorized in the United States since July 2022. Before being marketed in France, the drug must obtain the green light from the High Health Authority, which will assess its effectiveness and set its price and reimbursement by Health Insurance. . This assessment should take place in the first quarter of 2024. Opzelura will only be issued on prescription and treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of nonsegmental vitiligo.

What are the side effects of Opzelura?

According to the European Medicines Agency, the most common side effect is the appearance of acne at the application sites (5,8 %).

What are the contraindications?

• Hypersensitivity to the active substance or to any of the excipients mentioned above.
• The pregnancy
• breastfeeding

What will be the price of Opzelura?

For the moment, the price of Opzelura is not known in France. It is the High Health Authority that will set it following the evaluation of the drug. For your information, in the United States, the cost of Opzelura 1.5% topical cream is approximately $35.40 for a 60 gram tube, according to the pharmacy, or approximately 32 euros.

Sources :

– Opzelura, European Medicines Agency

– Department of dermatology and pediatric dermatology, CHU Bordeaux

– FDA approves topical treatment addressing repigmentation in vitiligo in patients aged 12 and older, FDA.gov

– French Association of Vitiligo: The drug Opzelura (Ruxolitinib) officially authorized in Europe

The rest period that Mujinga Kambundji granted himself in the wake of his European title in the indoor 60m at the beginning of March in Istanbul was therefore not enough for this inflammation (plantar fasciitis), which extends from the bone of the heel to toe, disappear.

Bothered by chronic foot pain since 2017, she decided to consult a specialist at the end of March on her return from Belek, Turkey, where the 30-year-old Bernese was in training camp. Mujinga Kambundji will make his comeback at best in Oslo (June 15), and should be in the game at Athletissima on June 30 in Lausanne.

“Obviously I would have preferred to start my season in May”underlines the double Swiss sportswoman of the year (2019, 2022), quoted in a press release from her management agency. “But the season is long, and the Worlds will fortunately take place at the end of August”from August 19 to 27 in Budapest, where she will aim for 3 finals (100, 200 and 4x100m).

ats/bao