OPSUMIT (macitentan), endothelin receptor antagonist

No clinical added value demonstrated in patients with class II or III functional status of pulmonary arterial hypertension by comparison with the available treatments

• OPSUMIT has Marketing Authorisation, in monotherapy or in combination, for the long-term treatment of adult patients with WHO class II or III functional status of pulmonary arterial hypertension (PAH). Its efficacy has been demonstrated in patients with idiopathic and heritable PAH, associated with connective tissue disorders and associated with corrected simple congenital heart disease.
• A study of morbidity and mortality versus placebo favours macitentan in a combined endpoint linking elements of differing weights. The results are based mainly on the reduction in episodes of exacerbations of PAH. No significant difference in terms of mortality was observed.