Therapy Areas: Inflammatory Diseases
Incyte Receives Positive CHMP Opinion for Ruxolitinib Cream for the Treatment of Non-segmental Vitiligo in Adults and Adolescents
27 February 2023 - - The European Medicines Agency Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age, US-based biopharmaceutical company Incyte (NASDAQ: INCY) said.

The CHMP opinion recommending the approval of ruxolitinib cream was based on data from two pivotal Phase 3 clinical trials (TRuE-V1 and TRuE-V2) evaluating the safety and efficacy of ruxolitinib cream versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older.

Results from the TRuE-V program, recently published in The New England Journal of Medicine, showed that treatment with ruxolitinib cream resulted in significant improvements in facial and total body repigmentation versus vehicle as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle, with a higher proportion of patients responding at Week 521.

The most common adverse reactions (incidence ≥ 1%) were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

The CHMP's opinion is now being reviewed by the European Commission, which has the authority to grant centralized marketing authorizations for medicinal products in the EU.

When approved, this will be the first approved vitiligo therapy available in the EU indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results in patchy loss of skin color from the progressive destruction of pigment-producing cells known as melanocytes. 

Overactivity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo.

In Europe, approximately 1.5 m patients are diagnosed with vitiligo (0.2 to 0.8% of the population), and its overall prevalence is estimated to be less than 1%, with the majority of patients (approximately 8 in 10) suffering from non-segmental vitiligo.

Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 306.

Vitiligo not only impacts physical health but also places a heavy burden on quality of life including employment and psychosocial health such as depression.

The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.

Each study enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo.

Ruxolitinib cream (Opzelura), a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, approved by the US Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States.

Opzelura is also approved in the US for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

In April 2022, Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan.

Opzelura is a trademark of Incyte.

Incyte's research and development efforts in dermatology are initially focused on leveraging our knowledge of the JAK-STAT pathway.

The company is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa.

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
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