After Johnson & Johnson last year changed its mind on its 2017 purchase of aprocitentan, the medicine's original maker has ushered the drug across the FDA finish line.

The once-daily drug, branded as Tryvio, is now approved to treat hypertension, or high blood pressure, when combined with other anti-hypertensive drugs, Idorsia said Wednesday.

The drug works to lower the blood pressure of patients who don’t get adequate control from other drugs, and therefore can cut the risk of fatal and non-fatal cardiovascular events such as strokes and heart attacks, Idorsia said in its release.

It’s been nearly 40 years since an oral anti-hypertensive therapy has gained FDA approval using a new therapeutic mechanism. Tryvio is an endothelin receptor antagonist that is designed to inhibit the binding of endothelin (ET)-1 to ETA and ETB receptors.

Unlocking the endothelin pathway

Tryvio is the first approved medicine to target the ET pathway as opposed to typical methods utilized by other antihypertensive drugs, including focusing on salt and water regulation.

Idorsia spotted the ET and hypertension connection early on, especially in patients who didn’t achieve complete control with other treatments, chief scientific officer Martine Clozel, M.D., explained in the release.

To reach FDA approval, the company conducted an “ambitious clinical program” in patients who were still hypertensive despite treatment with a minimum of three drugs and up to six antihypertensives, CEO Jean-Paul Clozel, M.D., added.

First, the med was tested on its own in a phase 2 study and then as an add-on for patients with resistant hypertension in a phase 3 trial. In the end, a 12.5 mg dose of Tryvio proved statistically significant over placebo in easing sitting systolic blood pressure from baseline levels.

“I’m very proud of the Idorsia team and very happy that physicians will have a new treatment option to treat patients whose blood pressure is not controlled,” the CEO added.

As for taking it to market, the company will “carefully craft” its Tryvio launch strategy over the next few months, president and general manager of Idorsia U.S., Tosh Butt, noted. Idorsia plans to make the drug available during the second half of this year.

The drugmaker, which has been researching endothelin science for over three decades, is celebrating the “significant medical progress” that the approval represents, Martine Clozel added.

“I am convinced that with the data we have seen, the approval of Tryvio heralds a new era of endothelin research beyond hypertension, where we intend to investigate the utility of aprocitentan for first-in-class applications in new indications,” she said in the release.

A $343 million hand-off 

At one point, Johnson & Johnson was confident in the drug, as well, which was demonstrated in the pharma giant's $230 million purchase of the medicine in 2017. J&J was originally meant to market Tryvio upon a potential approval, with royalties going to Idorsia.

Last September, the Big Pharma returned the drug to its original maker in a deal worth up to 306 million Swiss francs ($343 million).

The exchange came with specific terms that allow J&J to receive 30% of any money that stems from out-licensing or divesting the med, plus 10% of the proceeds from deals for any Idorsia products following Tryvio’s approval.

Analysts at Jefferies at one point projected peak sales of $2.5 billion for aprocitentan. Idorsia's revenues from the first nine months of 2023 came in at 131 million Swiss francs ($147 million).