INCY Obtains FDA Approval for Label Expansion of Ruxolitinib Cream

Core Viewpoint - Incyte (INCY) has received FDA approval for the label expansion of Opzelura (ruxolitinib) cream, now indicated for the treatment of mild to moderate atopic dermatitis in children aged two years and older [1][10]. Group 1: Product Approval and Efficacy - Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis [2]. - The FDA's approval was based on positive results from the phase III TRuE-AD3 study, which demonstrated the safety and efficacy of Opzelura in children aged 2 to less than 12 years [3]. - The study met its primary endpoint, showing significantly more patients treated with Opzelura achieved treatment success compared to those on a vehicle control [4]. - A secondary endpoint was also met, with patients showing at least a 75% improvement in the Eczema Area and Severity Index at week 8 [4]. - The safety profile of Opzelura was consistent with previous data, with no new safety signals observed [5]. Group 2: Sales Performance - Sales of Opzelura reached $283.2 million in the first half of 2025, reflecting a 37% year-over-year increase [5][10]. - The recent label expansion is expected to further boost sales of Opzelura [5]. Group 3: Company Strategy and Diversification - Incyte is focusing on diversifying its revenue base, as it remains heavily dependent on its lead drug, Jakafi, for top-line growth [7][11]. - Jakafi is a JAK1/JAK2 inhibitor approved for multiple indications, including polycythemia vera and myelofibrosis [8]. - Incyte has also entered a global collaboration with Qiagen to develop a diagnostic panel for myeloproliferative neoplasms, which could support its pipeline of investigational treatments [15][16]. Group 4: Market Performance - Year-to-date, Incyte's shares have increased by 24.5%, outperforming the industry growth of 6% [13].