ACT 132577 filed with FDA for difficult-to-control hypertension
Idorsia Ltd announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for ACT 132577 (aprocitentan), Idorsia’s investigational, novel dual endothelin receptor antagonist, for the treatment of patients with difficult-to-control hypertension
The NDA 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.
Full results from the PRECISION study were recently published in The Lancet “A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension” and presented as a Late-Breaking Science presentation during the American Heart Association (AHA) Scientific Sessions 2022.
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