Idorsia Wins FDA Approval in Hypertension Months After J&J Returned Rights to Drug

2024-03-21

临床3期上市批准临床结果并购引进/卖出

Pictured: Idorsia's office in Switzerland/iStock, yuelan Idorsia Pharmaceuticals on Wednesday announced that the FDA approved its endothelin receptor antagonist aprocitentan for the treatment of hypertension to reduce blood pressure in adults who had not reached adequate control on other drugs. Aprocitentan, which will now be sold under the brand name Tryvio, is an oral drug taken once-daily alongside other antihypertensive drugs. Tryvio is the first FDA-approved medication that targets the endothelin pathway for hypertension. Existing treatments act via different mechanisms, including the regulation of salt and water, the reduction of extracellular calcium influx into cells and the inhibition of the renin-angiotensin-aldosterone axis. Tosh Butt, president and general manager of Idorsia U.S., in a statement said that Tryvio’s approval will “provide physicians and patients with a novel medicine working in a new pathway” to treat uncontrolled hypertension and provide additional blood pressure control. Idorsia is currently preparing its launch strategy for Tryvio and expects to make the drug available to prescribers during the second half of 2024. Designed to be orally available, Tryvio is a small molecule drug that works by preventing the binding of the endothelin-1 ligand to its corresponding receptors. This mechanism of action dampens signaling cascades that bear many similarities with pathophysiology of hypertension, according to Idorsia’s announcement. Tryvio comes with a black box warning for embryo-fetal toxicity, flagging the risk of major birth defects when used during pregnancy. Tryvio should not be taken by patients who are pregnant or currently trying to become pregnant. Idorsia backed Tryvio’s regulatory bid with data from the Phase III PRECISION trial, which enrolled 730 patients who had systolic blood pressure (SBP) of at least 140 mmHg and who were taking at least three antihypertensive drugs. Before treatment, all patients were switched to a standard background regimen consisting of a calcium channel blocker, a diuretic and an angiotensin receptor blocker. Results showed that both the 12.5-mg and 25-mg dose levels of Tryvio could significantly reduce sitting SBP compared with placebo after four weeks of treatment. Treatment benefits were consistent across several patient subgroups, including according to age, sex, race, diabetes history and body mass index. Tryvio is only approved at its 12.5-mg dose. Tryvio’s approval comes months after Johnson & Johnson turned its back on the endothelin receptor blocker, electing in September 2023 to return Tryvio’s worldwide rights to Idorsia. The Indianapolis-based pharma bought into the promise of aprocitentan in 2017, paying $230 million for joint development and sole worldwide commercialization rights. Under the terms of the 2023 handoff, J&J will still be entitled to 30% of any out-licensing proceeds associated with Tryvio, as well as 10% of earnings from any product deal that Idorsia enters following approval. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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