Janssen Reports the NDA Submission of Macitentan and Tadalafil to the US FDA for Pulmonary Arterial Hypertension
Shots:
- The company has submitted the NDA to the US FDA seeking approval of single tablet combination therapy of macitentan (10mg) and tadalafil (40mg) for the long-term treatment of PAH in adult patients with WHO functional class (FC) II-III
- The application was based on the P-III study (A DUE) evaluating M/T STCT vs macitentan and tadalafil monotx. in 187 adult PAH patients across 148 sites in 19 countries globally. The trial met its 1EPs & showed a significant improvement in pulmonary hemodynamics & the safety profile was consistent with the safety profile of the individual components, macitentan, and tadalafil
- If approved, Janssen's comprehensive PAH portfolio will cover all guidelines-recommended treatment pathways
Ref: PRnewswire | Image: Janssen
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