Merck has received approval from the US Food and Drug Administration (FDA) for Zontivity (vorapaxar) for people at high-risk of heart attack or stroke.
The drug is indicated 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).
In patients who have a history of heart attack or with PAD who had no history of stroke or transient ischemic attack (TIA), the drug produced a 17% 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 revascularisation (UCR).
For the key secondary composite efficacy endpoint of CV death, MI and stroke alone, the drug produced a significant 20% relative risk reduction in these patients.
Results were driven by an 18% relative risk reduction in MI and a 33% relative risk reduction in first stroke.
The drug is the first in a new class called protease-activated receptor-1 antagonists, designed to decrease the tendency of platelets to clump and form a blood clot.
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FDA said that Zontivity increases users’ risks of developing life-threatening bleeding and the drug’s label includes a boxed warning describing this risk.
TIMI Study Group founder and chair of the landmark TRA 2°P TIMI 50 trial that supported the medicine’s approval Eugene Braunwald said a significant number of people in the US who have survived a heart attack or who have PAD remain at risk for another major cardiovascular event despite the use of existing treatments.
"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," Braunwald said.
The company said that there is no experience with use of Zontivity as the only administered antiplatelet agent, because the drug was studied only as an addition to aspirin and clopidogrel.
The drug addresses this additional pathway that is not targeted by aspirin or P2Y12 inhibitors such as clopidogrel.
Approval is based on data from the pivotal TRA 2°P TIMI 50 (‘Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events’) trial, one of the largest secondary prevention studies of an antiplatelet medicine carried out in about 26,449 patients.
In the randomised, double-blind, placebo-controlled trial, participants had a history of spontaneous MI within the prior two weeks to 12 months, ischemic stroke, or documented PAD.