Idorsia submits new drug application to FDA for aprocitentan to treat difficult-to-control hypertension

pharmafile | December 20, 2022 | News story | Research and Development  

Idorsia has announced that it has submitted a new drug application (NDA) to the FDA in hopes of gaining approval for aprocitentan; its novel and investigational dual endothelin receptor antagonist which treats patients with difficult-to-control hypertension.

Idorsia’s NDA includes data gathered in its phase 3 PRECISION study, in which aprocitentan showed statistically significant and clinically meaningful reduction in blood pressure (BP) as well as maintaining this lowered blood pressure for up to 48 weeks, when used in combination with background antihypertensive therapy in patients with resistant hypertension.

The drug was generally well tolerated and there were no significant safety concerns, although the most reported side effect was mild-to-moderate edema/fluid retention. Complete results from the trial were published in The Lancet.

Given that it has been more than 30 years since a new antihypertensive therapy has been developed, if approved aprocitentan could mark a huge improvement in the treatment of difficult-to-control hypertension.

Jean-Paul Clozel, MD and chief executive officer of Idorsia, stated: “I’m very pleased to see this application going to the FDA. Patients with uncontrolled blood pressure are at risk of major cardiovascular events. These risks are even higher for patients whose blood pressure is uncontrolled despite treatment with three or more antihypertensives, known as resistant hypertension. Controlling blood pressure for these patients, who often have several other aggravating risk factors such as obesity, diabetes, renal impairment, or ischemic heart disease, could prevent organ damage such as end-stage renal disease, heart failure or even death. The sooner we can bring anew therapeutic option for these patients, the better.”


Betsy Goodfellow

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