FDA Extends INCY's Application for Opzelura Label Expansion

Core Insights - Incyte's supplemental new drug application (sNDA) for ruxolitinib cream has had its FDA review period extended by three months to September 19, 2025, to allow for additional data review [1][2][7] - The sNDA aims to secure approval for treating children aged 2-11 years with mild to moderate atopic dermatitis (AD) [1][4] - Ruxolitinib cream, marketed as Opzelura, is already approved for patients aged 12 and older for the treatment of non-segmental vitiligo [3][5] Company Performance - Year-to-date, Incyte's shares have decreased by 0.9%, while the industry has seen a decline of 2.5% [2] - First-quarter net revenues from Opzelura cream reached $119 million, reflecting a 38% increase [5] Clinical Data - The sNDA is supported by data from the phase III TRuE-AD3 study, which demonstrated that a higher percentage of patients treated with Opzelura achieved treatment success compared to those using a non-medicated cream [4][7] - The study also met a secondary endpoint, with at least 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 [4] Portfolio Diversification - Incyte is actively working to diversify its portfolio and reduce reliance on its leading drug, Jakafi (ruxolitinib) [8] - The company has seen strong sales across all indications, with recent approvals of drugs like Pemazyre, Monjuvi, and Tabrecta contributing to this diversification [10] Competitive Landscape - Jakafi faces increasing competition, particularly from GSK's Ojjaara, which reported strong sales growth of £112 million in the first quarter of 2025 [13] - The patent protection for Jakafi is expected to expire in the coming years, which may impact future revenue [14]