Actelion initiates Phase III study to evaluate macitentan (Opsumit) in children with PAH

Author: Magdalena Kegel
Date Published: July-2016
Source: Scleroderma News

Actelion Ltd (ATLN.VX) announced today that it will be initiating a Phase III study to evaluate the effect of macitentan on delaying disease progression in children with PAH using a pediatric formulation of macitentan (Opsumit).

TOMORROW (pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide) is a multicenter, controlled, randomized, open-label event-driven study to assess the efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with PAH.