The Japanese Ministry of Health Labor and Welfare has granted marketing approval for a novel therapy developed by Actelion for pulmonary arterial hypertension (PAH). Opsumit (macitentan) was approved based on the latest data presented by the company with encouraging results regarding the effectiveness and safety of the investigational treatment in PAH patients.
The data that supported Opsumit’s approval to be commercialized in Japan was the result of a Japan-based study, as well as the landmark global phase III SERAPHIN study, which demonstrated the efficacy of the drug in improving pulmonary vascular resistance 6MWD and WHO function class. The SERAPHIN research analyzed the administration of 10 mg of macitentan per day and showed a 45% risk reduction of the composite morbidity-mortality endpoint in comparison with placebo.
“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,” said the president of Actelion Japan, Satoshi Tanaka, in a press release. 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.”
The drug had already been approved by the U.S. Food and Drug Administration (FDA) and by the European Union Commission in 2013. Its most common adverse events reported are nasopharyngitis, headache, anemia, bronchitis, urinary tract infection, pharyngitis and influenza. In Japan, Opsumit is going to be co-promoted by both Actelion and Nippon Shinyaku, while the company is planning on requesting marketing authorization in Australia, Canada and Switzerland as well.
“This is a great achievement for Actelion Japan,” added the CEO of Actelion, Jean-Paul Clozel MD. “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 province of Quebec recently became the first in Canada to publicly fund the drug Opsumit as a new treatment option for PAH. Opsumit (macitentan) is a novel dual endothelin receptor antagonist (ERA), which is taken orally once daily. It belongs to a class of drugs called endothelin receptor blockers, which act to relax the pulmonary arteries, decreasing blood pressure in the lungs.