Phase III TRuE-AD3 study of Opzelura meets primary endpoint in atopic dermatitis – Incyte

Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least 2 to <12 years) with atopic dermatitis (AD). The study met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success […]

Incyte announces FDA approval of Jakafi for treatment of chronic graft-versus-host disease

Incyte has announced that the FDA has approved Jakafi (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. “GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment […]

FDA approves Opzelura cream for mild to moderate atopic dermatitis – Incyte

Incyte announced that the FDA has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (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. Opzelura is the first and only topical formulation of a […]