Incyte Announces Health Canada Approval of OPZELURA® (ruxolitinib) Cream for the Treatment of Atopic Dermatitis (AD) and Nonsegmental Vitiligo

- First and only topical JAK inhibitor cream approved for atopic dermatitis (AD) that is not adequately controlled with conventional topical prescription therapies

- First and only treatment approved by Health Canada for repigmentation of nonsegmental vitiligo

SAINT-LAURENT, QC, Oct. 16, 2024 /CNW/ - Incyte Biosciences Canada today announced that Health Canada has granted a Notice of Compliance for OPZELURA® (ruxolitinib (as ruxolitinib phosphate)) cream 1.5%, a non-steroidal topical Janus Kinase (JAK) inhibitor, for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) or when those therapies are not advisable. OPZELURA also received a Notice of Compliance for a second indication, the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.1

Atopic dermatitis (AD), an inflammatory skin condition, is the most common form of eczema and is estimated to impact 17% of Canadians at some point in their lives. AD is characterized by itchy, inflamed skin, and is usually found behind the knees, the inside of the elbows, face, neck and hands.2 According to The Skin I'm In, a November 2022 Canadian Skin Patient Alliance and Eczéma Québec impact report, over 70% of respondents reported experiencing itch daily over the past week and half of all respondents reported dissatisfaction/strong dissatisfaction with current treatment, suggesting the need for a new treatment option.

"Uncontrolled atopic dermatitis impacts every aspect of a person's life, including the lives of those around them. Itch is relentless. They scratch and never get a good sleep. Scratching becomes a way of life. Their skin becomes thickened and often covered with scabs. Atopic dermatitis affects their quality of life in ways that we can only imagine. Not surprisingly, atopic dermatitis can lead to significant emotional and mental health challenges. A topical JAK inhibitor cream is an important therapy option for patients who are not responding to existing therapies," said Dr. Kim Papp, Board Certified Dermatologist and President of Probity Medical Research.

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.3 Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. People living with vitiligo may experience substantial psychological and psychosocial burden, including depression,4 and other mental health disorders,5 feelings of stigmatization,6 and hopelessness.7. It is estimated 0.5 to 1% of the population in Canada has vitiligo.8

"Up until this point, we've had very limited options for vitiligo treatment. Health Canada's approval of OPZELURA marks a critical milestone and step forward in supporting Canadians with vitiligo," said Dr. Harvey Lui, Professor, Department of Dermatology & Skin Science at the University of British Columbia. "As a dermatologist who sees the impact of vitiligo of patients and their families first-hand, I'm excited to be able to offer patients this completely new treatment option and approach."

"At Incyte, we research and develop innovative treatment solutions that address unmet needs for patients and we believe the Health Canada approval of OPZELURA shows our strong commitment to making a difference for people living with atopic dermatitis and vitiligo," said Christine Lennon, VP & General Manager of Incyte Biosciences Canada.

Health Canada's approval of OPZELURA is based on data from the TRuE-AD and TRuE-V clinical trial programs in atopic dermatitis and vitiligo, respectively.

About TRuE-AD

The TRuE-AD clinical trial program evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD) consists of two randomized, double-blind, vehicle-controlled Phase 3 studies: TRuE-AD1 ( NCT03745638 ) and TRuE-AD2 ( NCT03745651 ). Both studies enrolled more than 600 patients (age ≥12 years) who had been previously diagnosed with AD for at least two years and who were candidates for topical therapy.

For more information about TRuE-AD1, please visit https://clinicaltrials.gov/study/NCT03745638.

For more information about TRuE-AD2, please visit https://www.clinicaltrials.gov/study/NCT03745651.

About TRuE-V

The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 ( NCT04052425 ) and TRuE-V2 ( NCT04057573 ), evaluating the safety and efficacy of OPZELURA in patients with vitiligo. Each study enrolled approximately 300 patients (age ≥12 years) who have been diagnosed with nonsegmental vitiligo.

For more information about the TRuE-V1 study, please visit https://clinicaltrials.gov/study/NCT04052425

For more information about the TRuE-V2 study, please visit https://clinicaltrials.gov/study/NCT04057573

About OPZELURA® (ruxolitinib) Cream

OPZELURA is a novel cream formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib, and the first and only topical JAK inhibitor approved in Canada for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, and for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) or when those therapies are not advisable.

For important safety information about OPZELURA, including limitations of use, contraindications and both serious warnings and precautions, please review the product monograph here.

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

OPZELURA and the OPZELURA logo are registered trademarks of Incyte.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this presentation contain predictions, estimates and other forward-looking statements, including any discussion of whether and when OPZELURA might provide a successful treatment option for Canadian patients with AD or vitiligo.

These forward-looking statements are based on Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by Heath Canada, FDA, EMA, and other regulatory agencies; the efficacy or safety of Incyte's products; the acceptance of Incyte's products in the marketplace; market competition; unexpected variations in the demand for Incyte's products; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte's products; sales, marketing, manufacturing and distribution requirements, including Incyte's ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; variations in foreign currency exchange rates; and other risks detailed in Incyte's reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca.

SOURCE Incyte Biosciences Canada