The company has submitted a MAA to the EMA for aprocitentan (dual endothelin receptor antagonist) for the treatment of patients with resistant hypertension
The MAA was based on the results from a comprehensive clinical and non-clinical development program incl. the P-III registration study (PRECISION) consisted of three sequential parts (Part 1/2/3) evaluating Aprocitentan in 730 patients at hospitals or research centers in EU, North America, Asia, and Australia
The results showed that the patients treated with aprocitentan achieved a significant and clinical reduction in blood pressure which was maintained for ~48wks. when added to combination background antihypertensive therapy. The therapy was well tolerated with no major safety concerns
Ref: GlobeNewswire | Image: Idorsia
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