FDA approves new hypertension drug months after Idorsia reacquired rights for $343M
Idorsia Pharmaceuticals U.S. has received U.S. Food and Drug Administration (FDA) approval for aprocitentan, the company’s new medication for treating high blood pressure in patients who are already taking other antihypertensive drugs and still need additional help. Idorsia sells aprocitentan, an endothelin receptor antagonist, under the brand name Tryvio. The drug is designed to be taken once daily, with or without food.
Idorsia Pharmaceuticals U.S is the Pennsylvania-based American division of Idorsia, a global pharmaceutical research company. The plan is to make aprocitentan (Tryvio) available during the second half of 2024.
“Today, there are millions of Americans whose blood pressure is not well-controlled despite existing therapies,” Jean-Paul Clozel, MD, Idorsia’s CEO, said in a prepared statement. “This is a major public health issue leading to a high incidence of cardio- and cerebrovascular events. In order to help address this issue, Idorsia developed aprocitentan, an endothelin receptor antagonist suited to the treatment of these patients. Idorsia conducted an ambitious clinical program in patients remaining hypertensive despite a minimum of three drugs at their optimal dose and sometimes up to four, five, or even six antihypertensives.”
Last September, Idorsia reacquired the development and commercialization rights to aprocitentan from Janssen for 306 million Swiss francs, or approximately $343 million. That amount may vary depending on Idorsia’s final revenues in the years ahead.
“I’m happy that we have come to an agreement for the return of aprocitentan to Idorsia,” Clozel said at the time. “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.”
FDA’s decision guided by PRECISION study findings
The FDA’s approval was based in part on data from the PRECISION study, which was sponsored by Idorsia with assistance from Janssen. The analysis included data from 730 adult patients with systolic blood pressure ≥140 mmHg who were already prescribed at least three antihypertensive medications. After a “placebo run-in period” of four weeks, patients were randomized to either take aprocitentan or a placebo for another four weeks. Then, all patients were given aprocitentan daily for 32 weeks before patients were re-randomized to either receive aprocitentan or a placebo during a 12-week “withdrawal period.”
Overall, aprocitentan was consistently associated with reducing the blood pressure of patients in all subgroups.
“When designing PRECISION, we did not shy away from including patients who are most at risk of the serious negative consequences of hypertension,” Alberto Gimona, MD, head of global clinical development for Idorsia, explained in the company’s announcement. “In addition, while all patients needed to be on three antihypertensives to join the study, 63% of patients were on four or more anti-hypertensives. The study was therefore truly reflective of the real-world patient population whose blood pressure is not adequately controlled on other drugs. Tryvio demonstrated a clear and consistent effect across all endpoints of blood pressure measurement and in key sub-populations.”
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