Opsumit macitentan regulatory update

Actelion submitted an NDA to FDA for Opsumit macitentan to treat pulmonary arterial hypertension. The application is based on data from the Phase III SERAPHIN trial, which showed Opsumit met the primary endpoint of reducing the risk of a morbidity or mortality event compared to placebo. Low-dose Opsumit reduced the risk by 30%, while the high dose had a 45% reduction. Nippon has rights to co-develop and co-commercialize the product in Japan. Opsumit is a tissue-targeting endothelin receptor antagonist (see BioCentury, May 7). ...