Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
