Incyte Canada Announces Health Canada approval of Opzelura® (Ruxolitinib) Cream for the Treatment of Atopic Dermatitis in Children Ages 2-11

• First and only topical JAK inhibitor cream approved in Canada for pediatric atopic dermatitis (AD)
• This milestone marks the third Canadian regulatory approval for Opzelura, expanding the approved indication to treat mild to moderate AD in certain patients 2+ years of age

SAINT-LAURENT, QC, Oct. 15, 2025 /CNW/ - Incyte Biosciences Canada today announced that Health Canada has approved 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 pediatric patients 2 years of age or older, whose disease is not adequately controlled with conventional topical prescription therapies (topical corticosteroids, topical calcineurin inhibitors) or when those therapies are not advisable.¹

"I see the debilitating impact of atopic dermatitis in my clinic every day. The disease disrupts sleep, causing chronic itch and negatively impacts quality of life. Poorly managed atopic dermatitis can also have an immense impact to a patient's – and their families – emotional wellbeing," said Dr. Alim R. Devani, Canadian-certified dermatologist practicing at the Skin Health & Wellness Centre and investigator on the TRuE-AD3 trial. "The TRuE-AD3 clinical trial results show efficacy for Opzelura with pediatric patients. This indication is an important step forward in offering clinically proven therapies to support effective disease management."

Atopic dermatitis (AD) is an inflammatory skin condition, which is characterized by itchy, inflamed skin.² It is the most common form of eczema, with the majority of patients having mild-to-moderate disease severity.³

"Atopic dermatitis can have profound impacts on everyday life for sufferers and their families. As a challenging condition to manage, the approval of new therapies offers more options and hope for Canadian patients," said Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. 

Health Canada's recent approval of Opzelura in pediatric patients with AD was based on data from the pivotal Phase 3 TRuE-AD3 trial, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with AD. The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator's Global Assessment-treatment success (IGA-TS) than patients treated with vehicle control (non-medicated cream) at Week 8. During the long-term safety period, the proportion of subjects with an IGA of 0 (clear) or 1 (almost clear) remained high at study visits during Weeks 8 through 52 for subjects in the Opzelura treatment group who continued on the study and applied Opzelura on an intermittent, as needed basis. The safety and efficacy of Opzelura in pediatric patients under 2 years of age have not been established for atopic dermatitis.¹

The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous AD studies, and no new safety signals were observed. The most common treatment-related adverse event among patients treated with Opzelura was application site reaction (including application site pain, application site irritation, application site discomfort; 5% and 0% in vehicle arm). These events were mild and did not lead to treatment interruption. During the 8-week vehicle-controlled period, COVID-19 (4% and 2%), pyrexia (2% and 0%), and white blood cell decreased (including leukopenia; 2% and 0%) were also reported by subjects treated with Opzelura and by subjects who applied vehicle cream, respectively. Adverse reactions such as upper respiratory tract infection and nasopharyngitis applicable to 12 years of age and older were also observed in subjects 2 to 11 years of age at higher frequencies (9% vs 3% and 6% vs 2%, Opzelura vs vehicle cream, respectively). No serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses were reported during the 8-week vehicle-controlled period. When compared with subjects aged 12 years and older with atopic dermatitis, there were no meaningful differences in the safety profile of Opzelura.

"Children deserve to have relief from the effects of atopic dermatitis, while helping to give families peace of mind," said Christine Lennon, Vice President and General Manager of Incyte Biosciences Canada. "Opzelura's expanded indication to treat children with AD as young as 2 years of age, reflects Incyte's commitment to research and innovation, while addressing the unmet needs in dermatology care for Canadian patients."

In October 2024, Health Canada approved Opzelura for the topical treatment of atopic dermatitis and nonsegmental vitiligo in adult and pediatric patients 12 years of age or older.

About TRuE-AD3¹
TRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study, published in the Journal of the American Academy of Dermatology, enrolled over 300 patients (age ≥2 to <12 years) diagnosed with AD for at least three months and who were candidates for topical therapy.

Patients with an Investigator's Global Assessment (IGA) score of 2 to 3 (a measure of disease severity), and with AD on 3% to 20% of their Body Surface Area (BSA; excluding scalp) were randomized 2:2:1 to receive ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; or vehicle (non-medicated cream) BID. Patients who successfully completed an efficacy assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with their same treatment group (ruxolitinib cream 0.75% or 1.5% BID). Patients initially randomized to vehicle cream were re-randomized (1:1) in a blinded manner to one of the active treatment groups.

The primary endpoint of TRuE-AD3 is the proportion of patients achieving an Investigator's Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. The study also tracked the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

For more information about the study, please visit https://www.clinicaltrials.gov/study/NCT04921969.

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 2 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.

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.

Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this presentation, including the potential for Opzelura to be a successful treatment option for pediatric patients with AD, contain predictions, estimates and other forward-looking statements. 

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 and its Form 10-Q for the quarter ended June 30, 2025.  Incyte disclaims any intent or obligation to update these forward-looking statements.

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¹ Incyte Biosciences Canada. Opzelura Product Monograph. www.incytebiosciences.ca 

² Canadian Dermatology Association. Eczema. Accessed from https://dermatology.ca/public-patients/skin/eczema/

³ Gooderham MJ, Hong HC, Lynde C, Papp KA, Yeung J, Lui H, Miller-Monthrope Y, Ringuet J, Turchin I, Prajapati VH. Canadian Consensus Guidelines for the Management of Atopic Dermatitis with Topical Therapies. Dermatol Ther (Heidelb). 2025 Jun;15(6):1467-1485. doi: 10.1007/s13555-025-01386-2. Epub 2025 Apr 25. PMID: 40279086; PMCID: PMC12092898. 

SOURCE Incyte Biosciences Canada

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