Opsynvi, Macitentan Plus Tadalafil, Approved in Canada for PAH

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by Yedida Y Bogachkov PhD |

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Opsynvi for PAH | Pulmonary Hypertension News | approval illustration

Opsynvi, a fixed-dose oral combination of macitentan and tadalafil, was approved by Health Canada for the long-term treatment of pulmonary arterial hypertension (PAH).

It is for use by patients on stable doses of its two active compounds: macitentan (sold as Opsumit) at 10 mg and tadalafil (sold as Adcirca) at 40 mg.

Marketed by Janssen, Opsynvi was approved as a more convenient, once-daily treatment to help ease symptoms in people with World Health Organization (WHO) functional class II or III PAH that is idiopathic (no known cause) or hereditary, or associated with connective tissue disease or congenital heart disease.

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“While there is no cure, there have been considerable advancements in [PAH] care and we now have a gold standard option to improve pulmonary vascular resistance, lessen disease morbidity and reduce right heart impact,” Lisa Mielniczuk, MD, 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, said in a press release.

“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,” Mielniczuk added. “As a combination therapy, OPSYNVI conveniently offers two therapies in one daily pill simplifying treatment.”

PAH is a form of pulmonary hypertension in which the right side of the heart is affected. The pulmonary arteries, the blood vessels that transport blood through the lungs, are narrowed and stiff, leading to increased blood pressure within the lungs. If untreated, PAH can cause the right ventricle of the heart to fail.

Opsumit, an endothelin-receptor antagonist, works by lessening the contraction and narrowing of blood vessels. Adcirca, a phosphodiesterase type-5 inhibitor, is intended to relax the smooth muscle cells of arteries, leading to blood vessel widening and lower blood pressure.

Health Canada based its approval on three different comparative studies demonstrating the equivalence of Opsynvi as macitentan at 10 mg and tadalafil at 40 mg to Opsumit (macitentan 10 mg) plus Adcirca (tadalafil 40 mg) administered separately, the release reported.

“As part of our commitment to investing in research and understanding the science to advance innovative treatment options, today marks an important day for Canadians living with Pulmonary Arterial Hypertension. This new once daily treatment helps simplify patient care for the long-term treatment of PAH,” said Neil Davie, PhD, global therapeutic area head and research & development external innovation leader, pulmonary hypertension, at Janssen-Cilag.

Janssen and Janssen-Cilag are part of Johnson & Johnson.