Press release
Incyte Announces Additional FDA Approval of Opzelura® (Ruxolitinib) Cream in Children Ages 2-11 with Atopic Dermatitis
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
About this update from Incyte Corporation
[{"type":"text","content":"\n\nOpzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD)\n\n\n\nPhase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified\n\n\n\nThis 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\n\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (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.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918551027/en/OpzeluraⓇ (ruxolitinib) cream 1.5% logo\n“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.”\n\n\nThe 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","length":3045,"tagName":"div"}]