ACT 132577 filed with EU for resistant hypertension
Idorsia announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for ACT 132577 (aprocitentan), Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with resistant hypertension
The MAA includes data from a comprehensive clinical and non-clinical development program. In the Phase III registration study, PRECISION, aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) which was maintained for up to 48 weeks when added to combination background antihypertensive therapy in patients with resistant hypertension. In PRECISION, aprocitentan was generally well tolerated with no major safety concerns. The most frequent adverse event with aprocitentan was mild-to-moderate edema/fluid retention.
See "Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase III trial":VOLUME 400, ISSUE 10367, P1927-1937, DECEMBER 03, 2022; Prof Markus P Schlaich, MD , Marc Bellet, MD, Prof Michael A Weber, MD,Parisa Danaietash, PhD., Prof George L Bakris, MD, Prof John M Flack, MD,et al.Published:November 07, 2022DOI:https://doi.org/10.1016/S0140-6736(22)02034-7.
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