Opsynvi becomes the first and only Health Canada-approved once daily, fixed dose, combination treatment for pulmonary arterial hypertension. -Janssen Pharmaceuticals.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that Health Canada approved Opsynvi (macitentan 10mg and tadalafil 40mg) for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable, or associated with connective tissue disease or congenital heart disease.

Opsynvi should be used in patients who are currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg (20mg x 2) as separate tablets.

“PAH is a progressive disease that can affect people of any age or ethnic background. While there is no cure, there have been considerable advancements in care and we now have a gold standard option to improve pulmonary vascular resistance, lessen disease morbidity and reduce right heart impact,” said Dr. Lisa Mielniczuk, Director of the Pulmonary Hypertension Program at the Ottawa Heart Institute and Co-Vice Chair of the Pulmonary Hypertension Association of Canada’s Board of Directors. “Canadians living with PAH often have co-morbidities and are taking multiple treatments which can understandably lead to a high pill burden and reduced medication adherence. As a combination therapy, Opsynvi conveniently offers two therapies in one daily pill simplifying treatment for patients.”

Health Canada’s approval is based on three comparative bioavailability studies, which demonstrated the bioequivalence of a single dose of macitentan 10 mg and tadalafil 40 mg as the Opsynvi fixed dose combination tablet to Opsumit (macitentan 10 mg) and Adcirca (tadalafil 40 mg) co-administered as individual tablets in healthy patients.

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