What is Opzelura used for?

Opzelura (ruxolitinib) cream is used to treat moderate atopic dermatitis.

What were the results of the TRuE-AD4 trial?

The trial showed positive efficacy and safety data for Opzelura after 24 weeks.

Where were the trial results presented?

The results were presented at the 2026 European Academy of Dermatology and Venereology.

Who were the participants in the trial?

Participants included adults with moderate atopic dermatitis who did not respond to other treatments.

Opzelura Cream Shows Efficacy in Phase 3 Trial

Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis

• If approved, Opzelura®(ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in theEuropean Union(EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failed

• AD, the most common type of eczema which affects 230 million people globally,1is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2

• Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5

MORGES,Switzerland--(BUSINESS WIRE)--Jun. 26, 2026--Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency(EMA) has issued a positive opinion recommending the approval of Opzelura®(ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate.

“AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults inEuropewith moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head ofIncyte International. “If approved by theEuropean Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.”

The positive CHMP opinion is based on results from the pivotal Phase 3 TRuE-AD4 study (NCT06238817), supported by the Phase 3 TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies, evaluating the safety and efficacy of ruxolitinib cream in adults with AD.4,6,7

InTRuE-AD4, ruxolitinib cream significantly improved the clinical signs and symptoms of moderate AD, including itch, as early as Day 2 and was well tolerated in adults who had an inadequate response, intolerance or contraindication to both TCSs and TCIs.3The TRuE‑AD4 study met its co‑primary endpoints at Week 8, with a statistically significantly higher proportion of patients on ruxolitinib cream versus vehicle cream achieving a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI75), and, separately, 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).3

Efficacy was maintained following the initial treatment period with 84.3% of patients achieving EASI75 and 70.6% achieving IGA-TS with as needed therapy at Week 24.5Mean affected body surface area (BSA) decreased markedly from 15.1% at baseline to 2.5% at Week 8 and remained low at Week 24 (2.5%), while itch relief (NRS4; ≥4-point improvement in Itch Numeric Rating Scale) remained high (74.3% at Week 8 and 64.7% at Week 24) with ruxolitinib cream treatment.3,5

Additionally, patients treated with ruxolitinib cream also showed improvements in quality of life, with mean Dermatology Life Quality Index (DLQI) scores improving from 19.3 at baseline to 4.3 at Week 8, compared with 19.1 to 10.7 with vehicle cream (control).3

Ruxolitinib cream was well tolerated, with no serious infections, major adverse cardiovascular events, malignancies or thromboses reported during the 24-week treatment period.4The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).3

“In clinical practice, many adults with moderate AD do not achieve the level of disease control they need, despite available topical therapies, and the impact on quality of life can be considerable,” said Dr.Andreas Wollenberg, Professor of Dermatology and Allergy, University HospitalAugsburg, Germany. “The data supporting this positive CHMP opinion suggest that ruxolitinib cream may offer an effective new topical treatment option for appropriate adult patients inEuropeand may help delay or prevent progression to systemic therapy, potentially helping to address an important gap for those who have struggled to achieve lasting relief.”

AD, the most common type of eczema, is a chronic, recurring, inflammatory and highly pruritic skin condition that affects up to 4% of adults worldwide, with an estimated prevalence of 4.4-7.1% of adults in Europe.2,8,9,10Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust.2

The CHMP opinion is now being reviewed by theEuropean Commission(EC), which has the authority to grant approval for all centrally authorized products in theEuropean Union(EU). If approved, this would be the second indication for Opzelura in the EU, which was previously approved by the EC for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

About TRuE-AD4

TRuE-AD4 (NCT06238817) is a randomized, double-blind, vehicle-controlled Phase 3b study designed to evaluate the efficacy and safety of Opzelura®(ruxolitinib) cream in adults with moderate atopic dermatitis (AD). The study enrolled 241 patients (≥18 years old) who met the specific inclusion criteria, including an IGA (Investigator's Global Assessment) score of 3 and anEASI(Eczema Area and Severity Index) score greater than 7 at both screening and Day 1, and who have AD on 10% to 20% of their Body Surface Area (BSA; excluding scalp). Patients also had to have a documented history of inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) within the 12 months prior to the screening visit.

Patients were randomized 2:1 to receive Opzelura applied twice daily (BID) or vehicle (non-medicated cream) BID. At Week 8, patients who achieved EASI50 continued double-blind, BID treatment, applied as needed for an additional 16 weeks. Patients for whom EASI50 was not achieved at two consecutive visits ≥1 week apart were eligible to enter the escape arm at Week 8 or later, in which open-label Opzelura cream was applied as needed.

The co-primary endpoints of TRuE-AD4 were the proportion of patients achieving IGA 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, and EASI75, defined as ≥75% improvement inEASIscore, at Week 8. Secondary endpoints included the proportion of patients with a ≥4-point improvement in NRS4 (≥4-point improvement in Itch Numeric Rating Scale) score at various time points. Other efficacy measures included the proportion of patients who achieved IGA-TS, NRS4, EASI75, a reduction from baseline in the affected body surface area (%BSA), change from baseline in the skin pain NRS score, EASI50 and more, measured at various time points. The study also tracked the frequency, duration and severity of adverse events associated with the use of Opzelura.

For more information on the study, visithttps://www.clinicaltrials.gov/study/NCT06238817.

About Opzelura®(ruxolitinib) cream

Opzelura (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by theU.S. Food & Drug Administrationfor 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 inthe United States. Opzelura is also approved in theU.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 2 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.

InEurope, Opzelura®(ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incytehas worldwide rights for the development and commercialization of Opzelura.

Opzelura is a registered trademark ofIncyte.

For more information, see the OpzeluraSmPC.

About Incyte®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology, and Inflammation & Autoimmunity.

To learn more, visitIncyte.comandInvestor.Incyte.com. Follow us on social media:LinkedIn,XandInstagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding whether and when ruxolitinib cream might become a new treatment option for patients in the EU with moderate AD; ruxolitinib cream’s potential to delay or prevent progression to systemic therapy; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data 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; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s products; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

1Tiang J, Zhang, D Yang, Y, et al. Global epidemiology of atopic dermatitis: a comprehensive systematic analysis and modelling study. BrJ Dermatol. 2023 Dec 20;190(1):55-61. doi: 10.1093/bjd/ljad339

2Global Atopic Dermatitis Atlas. Global report on atopic dermatitis 2022. Available at:https://www.eczemacouncil.org/assets/docs/global-report-on-atopic-dermatitis-2022.pdf. AccessedJune 2026

3Carrascosa JM, Prajapati VH, and Hong HC, et al. Efficacy and safety of ruxolitinib cream in adults with moderate atopic dermatitis: results from TRuE-AD4, a phase 3b, randomized, double-blind, vehicle-controlled study. Results presented at the International Symposium on Atopic Dermatitis (ISAD), Melbourne, Australia, 2025. Available at:https://document.isad.org/meeting/2025/Melbourne/ActaDV-105-Suppl-ISAD-2025-Melbourne_abstract-book.pdf. AccessedJune 2026

4ClinicalTrials.Gov. A study to evaluate the efficacy, and safety study of ruxolitinib cream in adults with moderate atopic dermatitis (TRuE-AD4). Available at:https://clinicaltrials.gov/study/NCT06238817. AccessedJune 2026

5Wollenberg A, Hong HC, Agius E, et al. Long-term disease control and safety with ruxolitinib cream in adults with moderate atopic dermatitis following failure of prior topical therapies: results from the TRuE-AD4 phase 3b study. Results presented at theEuropean Academy of Dermatology and Venereology (EADV) Symposium,Athens, Greece, 2026. AccessedMay 2026. Available at:https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_symposium_2026/61731.pdf. AccessedJune 2026

6ClinicalTrials.Gov. Topical ruxolitinib evaluation in atopic dermatitis study 1 (TRuE AD1) - an efficacy and safety study of ruxolitinib cream in adolescents and adults with atopic dermatitis. Available at:https://clinicaltrials.gov/study/NCT03745638. AccessedJune 2026

7ClinicalTrials.Gov. TRuE AD2 - an efficacy and safety study of ruxolitinib cream in adolescents and adults with atopic dermatitis. Available at:https://clinicaltrials.gov/study/NCT03745651. AccessedJune 2026

8Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey.Allergy. 2018;73(6):1284-1293. Link to source (https://pubmed.ncbi.nlm.nih.gov/29319189/)

9Silverberg JI, Barbarot S, Gadkari A, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study.Ann Allergy Asthma Immunol. 2021;126(4):417-428.e2. Link to source (https://pubmed.ncbi.nlm.nih.gov/33421555/)

10Eckert L, Gupta S, Gadkari A, et al. Burden of illness in adults with atopic dermatitis: Analysis of national health and wellness survey data fromFrance,Germany,Italy,Spain, and theUnited Kingdom.J Am Acad Dermatol.2019;81(1):187-195. Link to source (https://pubmed.ncbi.nlm.nih.gov/30905805/)