Incyte announces additional FDA approval of Opzelura

Incyte (INCY) “announced that the FDA has approved Opzelura cream 1.5%, a topical Janus kinase inhibitor, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised children two years of age and older whose dsease is not well controlled with topical prescription therapies, or when those therapies are not recommended. The FDA approval of the supplemental New Drug Application 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 with AD. The TRuE-AD3 study met its primary endpoint with significantly more patients treated with Opzelura achieving Investigator’s Global Assessment-treatment success , 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 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, malignancies or thromboses were reported during the 8-week vehicle-controlled period. The most common adverse reaction was upper respiratory tract infection.”