FDA

Opzelura OK’d for atopic dermatitis in younger children

September 23, 2025

FDA has approved Opzelura (ruxolitinib) cream 1.5%, a topical Janus kinase (JAK) inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children ≥2 years of age whose disease isn’t well controlled with topical prescription therapies, or when those therapies aren't recommended.

Opzelura had previously been approved for the treatment of AD in adolescents ≥12 years of age.

Efficacy

Approval of the expanded indication was based on data from the phase 3 TRuE-AD3 trial (NCT04921969), which evaluated the safety and efficacy of ruxolitinib cream in children aged ≥2 to <12 years with AD. The 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 (56.5% vs. 10.8%). In addition, a secondary endpoint of patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at week 8 was also achieved.

Safety

The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, with no new safety signals detected. No serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses were reported during the 8-week vehicle-controlled period.

The most common adverse reactions reported in the trial were upper respiratory tract infection, COVID-19, application site reaction, pyrexia, and decreased WBC count.

Sources:

Opzelura (ruxolitinib cream) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215309s007lbl.pdf Revised September 2025. Accessed September 22, 2025.

Incyte announces additional FDA approval of Opzelura® (ruxolitinib) cream in children ages 2-11 with atopic dermatitis [News release]. 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-additional-fda-approval-opzelurar-ruxolitinib