Actelion Ltd has announced that SwissMedic has approved Opsumit® (macitentan) for PAH patients within Switzerland.
Opsumit is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in patients of WHO Functional Class II to III to reduce morbidity and the risk of mortality.
Opsumit is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled / oral prostanoids.
Jean-Paul Clozel, Chief Executive Officer of Actelion commented; "The SwissMedic approval, as one of the reference health authorities, is another positive step for Actelion and Opsumit in the global approval process. We are very proud that the convincing data from the SERAPHIN study and the translation into a label today, means that patients with PAH here in Switzerland can be treated with Opsumit. We will cooperate with the Swiss authorities to ensure availability for patients in due course."
The SwissMedic approval was based on data from the landmark Phase III SERAPHIN study. In the SERAPHIN study, treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio 0.55; 97.5% CI: 0.39 to 0.76; logrank p placebo.
The most commonly reported adverse drug reactions are nasopharyngitis (14%), headache (14%) and anaemia (13%). The majority of adverse reactions are mild to moderate in intensity.