The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly…
FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar
January 15, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. … Click here to read the entire…
Merck’s Vorapaxar Gets Positive FDA Review
January 13, 2014 by Leave a Comment
A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with…
The Return Of Vorapaxar, This Time For Post-MI Patients
August 27, 2012 by Leave a Comment
The once highly-promising novel antiplatelet agent vorapaxar, widely thought to be dead on arrival after unacceptably high serious bleeding rates were found in two large clinical trials, has now returned to active duty. On Sunday the drug’s sponsor, Merck, announced that it would seek approval of the drug, with a narrower indication than originally planned, based on new…
Novel Antiplatelet Agent Reduces CV Events But Increases Bleeding
March 24, 2012 by 1 Comment
Vorapaxar, the novel antiplatelet agent from Merck, appears to effectively reduce cardiovascular death and ischemic events in patients with MI, ischemic stroke, or peripheral vascular disease, but its potential utility is clouded by bleeding complications, including intracranial hemorrhage. Results from the TRA 2P-TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events) trial were presented…
Bleeding Problems Continue To Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar
February 7, 2012 by 1 Comment
In the large TRA-2P study of more than 26,000 patients with MI, ischemic stroke, or documented peripheral vascular disease, the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke or urgent coronary revascularization. But vorapaxar treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to…
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