Merck & Co., known as MSD outside of the U.S. and Canada, has announced promising results from its Phase 3 ZENITH trial evaluating Winrevair (sotatercept-csrk) for the treatment of pulmonary arterial hypertension (PAH). This progressive condition affects about 40,000 individuals in the United States.
The ZENITH study focused on adults classified as World Health Organization (WHO) functional classes III or IV who are at high risk of mortality. Participants received either Winrevair or a placebo, alongside their standard PAH treatments. The trial successfully met its primary endpoint, showing that Winrevair significantly reduced the risk of morbidity or mortality events compared to placebo.
Preliminary assessments indicated that adverse events were comparable between the treatment and placebo groups. In light of the strong efficacy results, an independent data monitoring committee has recommended that the trial be halted early.
All participants will now have the opportunity to receive Winrevair in an open-label extension study.
PAH is characterized by the thickening and narrowing of blood vessels in the lungs, which impedes blood flow and increases pressure, placing significant strain on the heart. The disease can progress rapidly, leading to limited physical activity, heart failure, and reduced life expectancy.
Winrevair is administered via injection and works by improving the balance between pro-proliferative and anti-proliferative signaling pathways to modulate vascular proliferation. The drug was approved by the European Commission in August for use in combination with other PAH therapies to enhance exercise capacity in adults with WHO functional classes II and III.
It is already approved in the U.S. and several other countries for treating PAH.
Eliav Barr, Merck’s senior vice president and chief medical officer, emphasized the significance of these findings, stating that they set a high standard for future PAH treatments and highlight Winrevair’s potential to change clinical practice in managing this serious condition.
Results from the ZENITH trial will be presented at an upcoming medical conference and submitted to regulatory authorities for review.
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