EMA’s CHMP issues positive opinion recommending approval of Opzelura® (ruxolitinib) cream for adults with moderate atopic dermatitis inadequately controlled by topical corticosteroids or calcineurin inhibitors. If approved, it will be the first steroid-free topical JAK inhibitor in the EU.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s (EMA) CHMP has issued a positive opinion recommending approval of Opzelura® (ruxolitinib) cream for adults with moderate atopic dermatitis (AD) whose disease is inadequately controlled with, or unsuitable for, topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). If the European Commission grants final approval, Opzelura will become the first steroid-free topical Janus kinase (JAK) inhibitor approved in the European Union for this patient population.
A New Topical Option for an Unmet Need
Atopic dermatitis is the most common form of eczema, affecting an estimated 230 million people worldwide. The chronic inflammatory skin disease causes persistent itching, redness, and recurrent flares that can significantly impair sleep, daily activities, and quality of life. While topical corticosteroids remain the standard first-line treatment, many patients experience inadequate disease control, treatment intolerance, or concerns about long-term steroid use.
Opzelura is a topical formulation of ruxolitinib, a selective JAK1/JAK2 inhibitor that reduces inflammatory signaling involved in AD without the use of corticosteroids.
Phase 3 Data Demonstrated Rapid and Sustained Disease Control
The CHMP opinion is primarily supported by the Phase 3b TRuE-AD4 trial (NCT06238817) and reinforced by findings from the Phase 3 TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) studies.
TRuE-AD4 enrolled 241 adults with moderate AD affecting 10% to 20% of body surface area who had an inadequate response, intolerance, or contraindication to both TCSs and TCIs. Patients were randomized in a 2:1 ratio to receive ruxolitinib cream or vehicle twice daily.
The study met both co-primary endpoints at Week 8. Significantly more patients receiving ruxolitinib cream achieved EASI75 and Investigator’s Global Assessment Treatment Success (IGA-TS) compared with vehicle. Patients also experienced clinically meaningful itch relief as early as Day 2.
Clinical benefits persisted through Week 24 with as-needed treatment. By Week 24, 84.3% of patients maintained EASI75, while 70.6% achieved IGA-TS. Mean affected body surface area declined from 15.1% at baseline to 2.5% by Week 8 and remained stable through Week 24. Improvements in itch and quality of life were also sustained, with Dermatology Life Quality Index (DLQI) scores decreasing from 19.3 at baseline to 4.3 at Week 8.
Ruxolitinib cream demonstrated a favorable safety profile throughout the 24-week study. No serious infections, major adverse cardiovascular events, malignancies, or thromboses were reported. The most common treatment-emergent adverse events were upper respiratory tract infection (10.6%) and nasopharyngitis (6.3%).
Expanding Treatment Choices for Adults with Moderate AD
Lee Heeson, Executive Vice President and Head of Incyte International, said the positive opinion brings Europe closer to offering adults with moderate AD a steroid-free topical treatment when conventional therapies are no longer suitable.
Dermatologist Prof. Andreas Wollenberg of University Hospital Augsburg added that many patients continue to struggle despite existing topical options. He noted that the clinical data suggest ruxolitinib cream could provide effective long-term disease control and may help delay progression to systemic therapies in appropriate patients.
Regulatory Path Forward
The CHMP recommendation now moves to the European Commission, which is expected to make the final regulatory decision applicable across all EU member states. Opzelura is already approved in the EU for non-segmental vitiligo with facial involvement and is approved in the United States for both vitiligo and mild-to-moderate atopic dermatitis. Approval in Europe would expand its indications and introduce the region’s first steroid-free topical JAK inhibitor for adults with moderate AD.
What This Means for Patients
If the European Commission approves Opzelura, adults with moderate atopic dermatitis in the EU will gain access to the first steroid-free topical JAK inhibitor for patients whose disease is not adequately controlled with conventional topical treatments. The cream demonstrated rapid itch relief, sustained improvement in skin symptoms, and a favorable safety profile, offering a new treatment option that may help some patients delay or avoid the need for systemic therapies.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.