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FDA approves Zontivity to reduce MI, stroke in high-risk patients
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The FDA has approved vorapaxar to reduce the risk for MI, stroke, CV-related death and coronary revascularization among patients who have previously experienced MI or peripheral artery disease, according to a press release.
The first-in-class protease-activated receptor-1 (PAR-1) antagonist targets thrombin-induced platelet activation.
The approval follows results from a clinical trial of more than 25,000 patients, in which the addition of Zontivity to other antiplatelet agents, such as aspirin or clopidogrel, reduced the incidence of MI, stroke, CV-related death and revascularization compared with placebo.
In January, the FDA’s Circulatory and Renal Drugs Advisory Committee voted 10-1 to recommend the approval of Zontivity for the reduction of atherothrombotic events among patients with a history of MI. In the meeting, panel members noted that the drug addressed an unmet clinical need, but were divided on whether the drug should also be approved as adjunctive therapy for patients with PAD.
“In patients who have had a heart attack or who have PAD, this drug will lower the risk of heart attack, stroke and CV death,” Ellis Unger, MD, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, stated in the release. “In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5% to 7.9% over a 3-year period — about 0.5% per year.”
The most commonly reported adverse event among Zontivity users is bleeding, and the labeling for the drug will include a boxed warning alerting clinicians to the risk. The drug is also not intended for patients with prior stroke, transient ischemic attack or intracranial hemorrhage.
In the release, the FDA advises health care providers to inform patients of the increased bleeding and bruising risk associated with Zontivity, and calls for patients to report “unanticipated, prolonged or excessive bleeding,” as well as any blood in their urine or stool.