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Important Opsumit (macitentan) News for NZ
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Opsumit® (macitentan) – New treatment for pulmonary arterial hypertension (PAH) recommended for listing on the New Zealand Pharmaceutical Schedule 

First clinically proven oral treatment to reduce the risk of a composite morbidity/mortality event in PAH patients1,2 

21 September, 2015: Actelion Pharmaceuticals Australia Pty Ltd announces the PTAC recommendation for Opsumit® (macitentan)1 10mg, a new endothelin receptor antagonist (ERA) for the treatment of pulmonary arterial hypertension (PAH), to be listed on the New Zealand Pharmaceutical Schedule for patients with PAH.

The new oral treatment is the first ERA to be clinically proven to reduce the risk of a composite morbidity/mortality event in PAH patients (by 45%, p<0.0001 vs placebo).2 PAH is a severe and life threatening form of hypertension between the heart and the lungs. 

Opsumit® is Medsafe (New Zealand Medicines and Medical Devices Safety Authority) approved, as monotherapy or in combination, for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II, III, or IV. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.1

PAH is a rare but potentially fatal disease causing high blood pressure in the arteries between the heart and lungs of patients. The chronic disease leads to increasing limitations on physical activity and life expectancy. Worldwide prevalence estimates vary from 15 to 26 cases per million up to 50 to 70 cases per million.3,4

Medsafe approved Opsumit® in November 2014. The approval was based on data from the SERAPHIN study. The study was the largest, longest and first Phase III outcome driven study for PAH, involving 742 patients across 40 countries. In the study, treatment with Opsumit® 10 mg resulted in a 45% relative risk reduction (hazard ratio 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity/mortality endpoint when compared to placebo.1,2 

Opsumit® was generally well tolerated by patients.1,5 The most common side effects included (>3% compared to placebo) nasopharyngitis, headache, anaemia, bronchitis, urinary tract infection, pharyngitis and influenza.

Opsumit® was previously approved by the US FDA, Health Canada and the EU Commission in 2013. It is also undergoing regulatory assessment worldwide. The treatment was developed over 14 years.



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