Janssen Reports the MAA Submission of Macitentan and Tadalafil to the EMA for the Treatment of Pulmonary Arterial Hypertension
Shots:
- The company submits the MAA to the EMA seeking approval for single-tablet combination therapy of macitentan (10mg) and tadalafil (40mg) for PAH in adult patients with WHO FC II-III
- The application was based on the P-III study (A DUE) evaluating M/T STCT vs macitentan & tadalafil monotx. in adult patients across 148 sites in 19 countries globally, showed that M/T STCT significantly improved pulmonary hemodynamics (blood flow through pulmonary blood vessels) over macitentan & tadalafil monotx
- The safety profile was consistent with the known safety profiles of macitentan & tadalafil with no new safety observations. If approved, Janssen's comprehensive PAH portfolio will cover all guidelines-recommended treatment pathways
Ref: Globenewswire | Image: Janssen
Related News:- Janssen Reports the NDA Submission of Macitentan and Tadalafil to the US FDA for Pulmonary Arterial Hypertension
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