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FDA Approves Ruxolitinib for Atopic Dermatitis


Incyte announced the FDA has approved its topical selective Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib (Opzelura) for the treatment of mild to moderate atopic dermatitis.

The FDA has approved ruxolitinib (Opzelura; Incyte), a topical selective Janus kinase (JAK)1/JAK2 inhibitor, for the treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable, according to a press release from Incyte.1

Ruxolitinib is the first and only topical JAK inhibitor approved in the U.S., according to Incyte. The FDA accepted the New Drug Application (NDA) for ruxolitinib and was granted priority review on March 12, 2021.2

“The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” said Hervé Hoppenot, CEO, Incyte. “At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases.”

The approval is backed by positive phase 3 data from Incyte’s TRuE-AD clinical trial program, which evaluated the topical in over 1,200 patients, ages 12 years and older, who had been diagnosed with atopic dermatitis for at least 2 years and who were also candidates for topical therapy. The NDA filing also included safety and efficacy data from a supplemental 44-week, open-label, long-term extension study of both TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651).

As previously reported by Dermatology Times®3, results of TRuE-AD1 showed 50% of the ruxolitinib cream 0.75% group and 53.8% of the ruxolitinib cream 1.5% group achieved the primary endpoint compared to 15.1% vehicle. Moreover, 56% of the ruxolitinib cream 0.75% group and 62.1% of the ruxolitinib cream 1.5% group achieved the secondary endpoint of 75% improvement or more in EASI score compared to baseline versus 24.6% vehicle.

In TRuE-AD2, 39% of patients treated with ruxolitinib cream 0.75% and 51.3% treated with 1.5% met the primary endpoint compared to 7.6% of the vehicle group. Also, more than 51% of patients in the 0.75% group and 61.8% of patients in the 1.5% group achieved 75% improvement or more in the EASI score from baseline, versus 14.4% vehicle, according to a press release announcing the study’s results.4

The most common (≥1%) treatment-emergent adverse reactions in patients treated with ruxolitinib in the studies included nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea. Incyte advises physicians to educate themselves about important safety information regarding ruxolitinib, including a recently issued Boxed Warning from the FDA for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, seen with JAK inhibitors for inflammatory conditions.

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at The George Washington University School of Medicine and Health Sciences. “As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”


1. Incyte announces u. S. Fda approval of opzelura™(Ruxolitinib) cream, a topical jak inhibitor, for the treatment of atopic dermatitis(Ad). Published September 21, 2021. Accessed September 21, 2021. https://www.businesswire.com/news/home/20210921006072/en/Incyte-Announces-U.S.-FDA-Approval-of-Opzelura%E2%84%A2-ruxolitinib-Cream-a-Topical-JAK-Inhibitor-for-the-Treatment-of-Atopic-Dermatitis-AD

2. Incyte announces acceptance and priority review of nda for ruxolitinib cream for atopic dermatitis. Press release. Incyte. Accessed March 12, 2021. https://investor.incyte.com/press-releases/press-releases/2021/Incyte-Announces-Acceptance-and-Priority-Review-of-NDA-for-Ruxolitinib-Cream-for-Atopic-Dermatitis/default.aspx

3. Hilton L. Ruxolitinib data positive for efficacy, safety. Dermatology Times. Accessed March 12, 2021. https://www.dermatologytimes.com/view/ruxolitinib-data-positive-efficacy-safety

4. Incyte announces first presentation of phase 3 data from the true-ad program of ruxolitinib cream at the revolutionizing atopic dermatitis virtual symposium. Press release. Incyte. Accessed March 12, 2021. https://investor.incyte.com/press-releases/press-releases/2020/Incyte-Announces-First-Presentation-of-Phase-3-Data-from-the-TRuE-AD-Program-of-Ruxolitinib-Cream-at-the-Revolutionizing-Atopic-Dermatitis-Virtual-Symposium/default.aspx

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