The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks.
The study depicted a greater reduction in PVR at 16wks. with Opsynvi vs macitentan/tadalafil monotx. The trial thereby met its co-primary endpoints by depicting a significant pulmonary hemodynamic improvement
Opsynvi is a combination of macitentan (endothelin receptor antagonist) & tadalafil (phosphodiesterase 5 (PDE5) inhibitor)
Ref: Johnson & Johnson | Image: Johnson & Johnson
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