Idorsia files for US FDA approval of aprocitentan

Switzerland-based Idorsia (SIX: IDIA) today announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aprocitentan, the firm’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.

According to analysts at Jefferies, aprocitentan could have a market opportunity of around $2.5 billion a year if approved as a drug that can help people with resistant hypertension meet their target blood pressure.