FDA Approves Zontivity to Reduce Risk of Heart Attacks and Stroke in High-Risk Patients
June 3, 2014 — The U.S. Food and Drug Administration (FDA) announced it approved Zontivity (vorapaxar) tablets to reduce the risk of heart attack, stroke, cardiovascular death and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Zontivity is the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke.
Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information (label) includes a boxed warning to alert healthcare professionals about this risk.
Zontivity must not be used in people who have had a stroke, transient ischemic attack (TIA) or bleeding in the head, because the risk of bleeding in the head is too great.
“In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 percent to 7.9 percent over a three-year period — about 0.5 percent per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.
Healthcare professionals should inform patients that they may bleed and bruise more easily when taking Zontivity. Patients should report to their healthcare professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. Zontivity will be dispensed with an FDA-approved patient medication guide that provides instructions for its use and important safety information.
In a clinical trial with more than 25,000 participants, Zontivity, added to other anti-platelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death and urgent procedures to improve blood flow to the heart (coronary revascularization) when compared to an inactive pill (placebo).
Zontivity is made by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc. of Whitehouse Station, N.J.
For more information: www.fda.gov, www.merck.com