CHMP recommends Opsumit (Actelion) for PAH

The CHMP has issued a positive opinion for Opsumit (macitentan), from Actelion, as monotherapy or in combination, for the long-term treatment of adults with Pulmonary Arterial Hypertension (PAH). The company said the European Commission is expected to render a final decision in two months.

The opinion was based on the Phase III SERAPHIN study involving 742 patients with PAH. Results demonstrated that Opsumit significantly lowered the risk of a morbidity or mortality event, which was the trial's primary endpoint, by 45 percent, compared with placebo. Additionally, the study showed a 50-percent reduced risk of PAH-related hospitalisation or death with Opsumit, versus placebo. Opsumit has recently gained FDA approval to treat adults with PAH.