Actelion recently announced that it has received marketing approval for Opsumit®, the trade name for macitentan, as a treatment for pulmonary arterial hypertension (PAH) from Japan’s Ministry of Health Labor and Welfare.
This approval was supported by data collected from a local assessment conducted in Japan and data from the SERAPHIN study, a global Phase III assessment. In these two studies, improvements in the WHO function class and in pulmonary vascular resistance were registered. Concerning the SERAPHIN study, researchers noted that daily treatment with 10 mg of macitentan caused a 45 percent risk reduction in the composite morbidity-mortality endpoint when compared to a placebo.
The President of Actelion Japan, Satoshi Tanaka, commented in a press release: “Opsumit represents a major step forward for the management of PAH as the first and only approved PAH treatment with proven long-term outcome efficacy. We are delighted to be able to add Opsumit to our PAH portfolio alongside epoprostenol ‘ACT’ and Tracleer as another crucial element in successful PAH management for physicians across Japan.”
Jean-Paul Clozel, Actelion’s CEO, said: “This is a great achievement for Actelion Japan. This approval is based on the SERAPHIN data and the local Japanese study performed by Actelion Japan. I am very happy that the Japanese PAH patients can soon benefit from Opsumit an innovative product discovered in our laboratories.”
The most frequent adverse events reported in the SERAPHIN study with a minimum frequency of 3 percent greater on macitentan than on placebo were headache, nasopharyngitis, bronchitis, anemia, pharyngitis, urinary tract infection and influenza.
The United States Food and Drug Administration approved Opsumit in October 2013 and the European Union Commission. Opsumit was approved by the US FDA in October 2013 and by the EU Commission in December 2013. Market introductions in Australia, Switzerland and Canada are being launched.
Launch activities are progressing rapidly with market introductions in the United States, European Union, Australia Canada and Switzerland.
Actelion Pharmaceuticals in Japan will be co-promoting Opsumit with Nippon Shinyaku in Japan. Both companies will be partnering to ensure that Opsumit will be made available to patients as quickly as possible.