FDA Approves Ruxolitinib for Mild to Moderate Atopic Dermatitis

The approval follows recent phase 3 trial data showing significant improvement in patient-reported outcomes for the treatment of atopic dermatitis.

The US Food and Drug Administration (FDA) has approved janus kinase (JAK) inhibitor cream therapy ruxolitinib (Opzelura) for the treatment of atopic dermatitis.

The approval, awarded to Incyte, is indicated for patients 12 years and older.

Ruxolitinib is the first and only topical formulation of a JAK inhibitor approved in the US. It has been recommended for patients with mild-to-moderate atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Earlier phase 3 data from the TRue-AD clinical trial program presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience detailed significant improvements in patient-reported outcomes for the treatment of atopic dermatitis.

The trial assessed a total of 1249 patients, 118 of whom were 12-15 years old with atopic dermatitis for ≥2.

Both double-blinded trials in the phase 3 data randomized patients 2:2:1 to either 0.75% or 1.5% ruxolitibinib cream, or vehicle cream, with each treatment administered twice daily for 8 weeks.

Investigators observed that ruxolitinib was linked to significant mean patient change from baseline in Patient-Oriented Eczema Measure (POEM) at week 8: -10.5 for 0.75% ruxolitinib; -11.0 for 1.5% ruxolitinib; -4.2 for vehicle (P <.0001).

Experts such as phase 3 trial study author Lawrence Eichenfield, MD, of the Rady Children’s Hospital and UC San Diego School of Medicine have noted the “robust trial profile” of ruxolitinib, adding that it could provide an alternative to high-cost injections.

“It does look like it’ll be something in our regimens of care that will allow to keep more people potentially clear or almost clear without their rash and minimal itch,” Eichenfield said in an interview with HCPLive.

In a press release, Chief Executive Officer of Incyte Hervé Hoppenot shared his enthusiasm over the FDA approval.

“The approval of Opzelurais an important advancement in the treatment of atopic dermatitis, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” Hoppenot said.

Incyte will continue to explore the potential of ruxolitinib cream in other immune-mediated skin diseases like vitiligo.