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FDA Approves Merck's ZONTIVITY™

Mon, 05/12/2014 - 8:00am

Merck announced that the FDA has approved ZONTIVITY™ (vorapaxar) for the reduction of thrombotic cardiovascular events in patients with a history of heart attack (myocardial infarction) or in patients with narrowing of leg arteries, called peripheral arterial disease (PAD). For patients with a history of heart attack or with PAD who had no history of stroke or transient ischemic attack (TIA), ZONTIVITY added to standard of care produced a significant 17 percent relative risk reduction over the three years of the study for the combined events of cardiovascular (CV) death, myocardial infarction (MI), stroke, and urgent coronary revascularization (UCR) [event rate 10.1 percent vs. 11.8 percent for placebo]. For the key secondary composite efficacy endpoint of CV death, MI and stroke alone, ZONTIVITY produced a significant 20 percent relative risk reduction in these patients [7.9 percent vs. 9.5 percent for placebo]. These results were driven by an 18 percent relative risk reduction in MI [5.4 percent vs. 6.4 percent for placebo] and a 33 percent relative risk reduction in first stroke [1.2 percent vs. 1.6 percent for placebo].

The prescribing information for ZONTIVITY includes a boxed warning regarding bleeding risk. ZONTIVITY is not for use in patients with a history of stroke, TIA or intracranial hemorrhage (ICH), or active pathological bleeding. Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding.

“A significant number of Americans who have survived a heart attack or who have PAD remain at risk for another major cardiovascular event despite the use of existing treatments,” said Eugene Braunwald, MD, TIMI Study Group founder and chair of the landmark TRA 2°P TIMI 50 trial that supported the medicine’s approval. “A new treatment option like ZONTIVITY is an important advance that can help to lower that risk for appropriate patients taking aspirin, clopidogrel, or both.”

There is no experience with use of ZONTIVITY as the only administered antiplatelet agent, because ZONTIVITY was studied only as an addition to aspirin and/or clopidogrel.

“Merck has a longstanding commitment to bringing forward important new cardiovascular medicines like ZONTIVITY to help address significant unmet medical needs,” said Dr. Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories.

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