Swiss biotech company Actelion Pharmaceuticals has launched Opsumit (macitentan) as a new treatment option for patients with pulmonary arterial hypertension (PAH) in England, where approximately 3,000 people receive disease-targeted drug therapy for the condition.
This comes as significant news for Actelion, after the Institut National d’Excellence en Santé et Services Sociaux (INESSS) recently decided not to include Opsumit on the list of medications covered by Quebec’s public drug insurance plan in Canada.
Opsumit is a prescription medicine used to treat PAH, a high blood pressure in the arteries of the lungs. The drug, indicated for use as a monotherapy or in combination for the long-term treatment of PAH in adult patients, is used to improve exercise ability, reduce some of the symptoms of PAH, help slow down the progression of the disease, and lower the chance of being hospitalized for PAH.
In December of last year, the drug received European Union marketing authorization, and England now becomes one of the first countries to make Opsumit available for prescription, after the National Health Services in Scotland made it available last month.
The safety and efficacy of Opsumit were demonstrated in the landmark study Seraphin, the longest and largest PAH clinical trial to date, and also the first long-term study to include a clearly defined, clinically-important morbidity/mortality primary endpoint. The effect of Opsumit on the morbidity and mortality endpoint was observed irrespective of whether or not patients were already treated with other therapies for PAH.