Print“But Zontivity comes with some serious bleeding risks and carries a black box warning to alert physicians to its potential for life-threatening and fatal bleeding. ”
The U.S. Food and Drug Administration has approved Merck’s Zontivity to reduce the risk of heart attack, stroke, cardiovascular death, and the 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, or PAR-1 antagonist. It is designed to decrease the tendency of platelets to clump together to form a blood clot and thus decreases the risk of heart attack and stroke.
But Zontivity comes with some serious bleeding risks and carries a black box warning to alert physicians to its potential for life-threatening and fatal bleeding. The FDA warned that it could not be used in people who have already had a stroke, transient ischemic attack, 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 3-year period – about 0.5 percent per year,” said Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.
Merck had blockbuster hopes for Zontivity, which was acquired through its $41 billion buyout of Schering Plough in 2009. But the bleeding risks soon put a damper on the patient population suitable for treatment. Still Merck sees a sizeable need as 7.6 million sufferers of a heart attack in the United States, many of them at great risk for a recurrence.
Merck is also beefing up its cardiovascular pipeline through its new $2.1 billion collaboration with Bayer to share in the rights for pulmonary hypertension treatment Adempas and a portfolio of new compounds in development to treat heart failure.
May 09, 2014
http://www.burrillreport.com/article-fda_approves_merck%e2%80%99s_zontivity_.html
