Actelion’s Opsumit demonstrates efficacy in phase III trial

Actelion has announced data from a new phase III clinical trial that underlines the benefits offered by its pulmonary arterial hypertension (PAH) therapy Opsumit.

The pharmaceutical company evaluated the macitentan-based treatment in a pivotal long-term trial called Seraphim, which showed that the drug delivered a significant and clinically relevant reduction in the risk of morbidity and mortality.

Opsumit was shown to minimise these dangers by 45 percent compared to placebo, while offering a strong and sustained benefit and an encouraging safety profile.

Moveover, secondary endpoint data revealed that Actelion's therapy reduced the risk of death or hospitalisation due to PAH, while showing a benefit in terms of minimising rates of all-cause mortality.

Dr Lewis Rubin, Emeritus Professor at the University of California, San Diego, said: "The Serpahin study clearly has shown that treatment with macitentan results in an improved outcome of patients with PAH and macitentan has the potential to change the course of the disease."

This comes after the firm submitted an application for approval of Opsumit to the US Food and Drug Administration earlier this week.