Posts Tagged ‘vorapaxar’

May 8th, 2014

Novel Antiplatelet Agent Vorapaxar Gains FDA Approval

The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (MI), 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 has experienced nearly as many […]

January 16th, 2014

FDA Advisory Panel Votes in Favor of Approval for Merck’s Vorapaxar

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. The committee voted in favor of the drug […]

January 13th, 2014

Merck’s Vorapaxar Gets Positive FDA Review

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 […]

December 16th, 2013

Possible New Lease on Life for Vorapaxar and Rivaroxaban for ACS

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and […]

October 15th, 2012

Selections from Richard Lehman’s Literature Review: October 15th

This week’s topics include PCI use in states with public reporting of outcomes; proneurotensin as a prognostic marker for CVD, diabetes, and mortality; vorapaxar for secondary prevention of thrombotic events in patients with previous MI; and atenolol vs. metoprolol for hypertension.

August 27th, 2012

The Return of Vorapaxar, This Time for Post-MI Patients

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 […]

May 30th, 2012

Reality Check: Do Reporters Spin Trial Results?

Do reporters spin trial results – or do some reporters just not understand the science well enough to report results accurately? I was thumbing through Nature Reviews/Cardiology when I happened on this headline in the section on Research Highlights: Vorapaxar beneficial in setting of prior MI, but not in patients who have experienced stroke. This long […]

March 24th, 2012

Novel Antiplatelet Agent Reduces CV Events But Increases Bleeding

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 […]

February 7th, 2012

Bleeding Problems Continue to Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar

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 treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to be […]

January 12th, 2012

Selections from Richard Lehman’s Weekly Review: Week of January 9th

This week’s topics: bariatric surgery, length of stay and MI, secondary prevention after ACS, and vorapaxar