The U.S. FDA has approved Idorsia's oral anti-hypertensive therapy, just months after J&J handed the rights to the drug back to the Swiss biotech.
With the approval, once-daily Tryvio (aprocitentan) becomes the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives.
Idorsia was spun out of Actelion as part of J&J's $30 billion acquisition in 2017. Then, in late 2017, J&J's Janssen Biotech paid $230 million to exercise its option to enter into a collaboration agreement with Idorsia to jointly develop and commercialize aprocitentan. But last September, Janssen decided to return the rights to the drug to Idorsia, along with a $343 million payment.
Tryvio was evaluated as a monotherapy in a phase 2 study in patients with hypertension, and as an add-on therapy in the phase 3 PRECISION study in patients with confirmed resistant hypertension.
Idorsia says it plans to make the treatment available to the millions of patients in the U.S. with hypertension that is not controlled by other drugs in the second half of 2024.
