New drug approved by FDA prevents clotting, lowers heart attack and stroke risk

FDA health regulators approved a new drug developed by Merck and Co. that prevents blood clots in patients who have had a heart attack or who suffer from peripheral artery disease.

by John Tyburski

Copyright © Daily Digest News, KPR Media, LLC. All rights reserved.

Firstpublished at Daily Digest News on May 8, 2014

In a news release Thursday, U.S. Food and Drug Administration officials announced that they had approved the use of vorapaxar tablets to reduce the risk of heart attack, stroke, cardiovascular death, and surgical procedures for treating peripheral artery disease or those with a history of heart attacks. The approval comes after a FDA advisory panel recommended the drug’s use, a decision which followed a 10-to-1 vote at the beginning of the year. The approved drug was developed by Merck and Co. and will be marketed under the name Zontivity.

Zontivity prevents blood platelets from aggregating and forming clots by blocking a receptor called protease-activated receptor-1 (PAR-1) and is the first in this new class of PAR-1 antagonists. By decreasing clot formation, Zontivity reduces the risk of heart attack and stroke, both catastrophic effects of aberrant clot formation. These risk reductions were observed in combination of Zontivity with other anti-platelet drugs in a placebo-controlled clinical trial with over 25,000 participants.

“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 3-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.

The delay in final approval stemmed from safety concerns surrounding serious and sometimes fatal bleeding in trial patients who received Zontivity. The marketed drug will include a Boxed Warning that will alert health care professionals and patients to the increased risk of serious bleeding. Due to great risk of bleeding in the head associated with Zontivity and certain conditions, Zontivity will not be prescribed to patients who have experienced stroke, transient ischemic attack, or bleeding in the head.