Actelion reports positive data from Opsumit trial

Actelion has announced positive data from Seraphin, a clinical trial assessing the benefits of Opsumit, its new therapy for pulmonary arterial hypertension (PAH).

A subgroup analysis of Seraphin has revealed that treatment-naive patients receiving Opsumit experienced significantly improved long-term outcomes, irrespective of the time from diagnosis to treatment initiation.

It was able to reduce the risk of morbidity/mortality by 60 percent compared to placebo in incident patients and 53 percent in prevalent patients, suggesting it can be an effective first-line therapy for both newly-diagnosed patients and those who have waited longer before starting treatment.

Dr Jean-Paul Clozel, chief executive officer of Actelion, said: "We are truly seeing the benefits to the PAH community of undertaking the largest and longest trial ever in PAH, and in focusing on the most clinically relevant endpoints of morbidity and mortality."

This comes in the same month that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Opsumit for EU approval in the long-term treatment of PAH in adult patients of WHO Functional Class II to III.