- Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD)
- Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified
- This milestone marks the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in non-immunocompromised patients 2+ years of age and nonsegmental vitiligo in patients 12+ years of age
Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (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 two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
“With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day,” said Bill Meury, Chief Executive Officer, Incyte. “At Incyte, we are committed to delivering innovative solutions that address every stage of a patient’s journey; this approval is another step toward addressing the real-world challenges faced by patients suffering from chronic skin conditions, including people living with atopic dermatitis.”
The FDA approval of the supplemental New Drug Application (sNDA) for Opzelura was based on data from the pivotal Phase 3 TRuE-AD3 trial, which evaluated the safety and efficacy of ruxolitinib cream in children (age ≥2 to <12 years) with AD.1 The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success (IGA-TS), a measure of treatment efficacy, than patients treated with vehicle control (non-medicated cream). 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.
The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data, and no new safety signals were observed. No serious infections, major adverse cardiovascular events (MACE), malignancies or thromboses were reported during the 8-week vehicle-controlled period. The most common adverse reaction was upper respiratory tract infection.
“Navigating a complex condition like atopic dermatitis can be very challenging for children, who currently have limited treatment options to meet their specific needs,” said Dr. Peter Lio, M.D., Clinical Assistant Professor of Dermatology & Pediatrics at Northwestern University Feinberg School of Medicine. “With this approval, we now have a new, non-steroidal topical option that expands how we care for kids with this chronic disease. This is a meaningful step forward and marks a significant advancement in our ability to better support our pediatric patients.”
AD, the most common type of eczema, is a chronic immune-mediated skin disease, which in the U.S. affects an estimated 2-3 million patients ages 2-11 and more than 21 million people 12 years of age and older.2,3 Signs and symptoms include irritated skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections.4
“As a parent of a child with atopic dermatitis, it has been challenging to see my daughter struggle growing up with her condition. There were many times her mother and I felt frustrated with the lack of treatment options that worked for our family, which was very difficult to manage as a parent,” said Adam Flores, father of Piper (age 10), who lives with AD. “We spent years searching for the right treatment for Piper and, after joining the Opzelura clinical trial, we finally saw real relief for her eczema symptoms. This approval brings hope for a new treatment to families like ours who have spent years searching for answers.”
“While every child’s journey with AD is unique, for many, the skin redness and irritation can profoundly impact their well being,” said Korey Capozza, Founder of Global Parents for Eczema Research (GPER). “When you’re managing a condition that can affect daily life, access to safe, effective, and age-appropriate options is critical. With limited, safe treatment options currently available, especially for younger children, the addition of new therapies that control symptoms is so important to meet the needs and goals for children with AD and their families.”
In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In July 2022, Opzelura was approved by the FDA for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Opzelura have access to Opzelura On TracTM, a patient support program providing tools and resources for patients along their treatment journey with Opzelura, including how to obtain, use and afford their prescription and refills. For more information, please visit https://www.opzeluraontrac.com/.
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