|
 The drug, vorapaxar, was approved to reduce the risk
of heart attacks, stroke, cardiovascular death and the need for
procedures to improve blood flow to the heart, the Food and Drug
Administration said.
Merck will sell the new medicine under the brand name Zontivity.
The approval follows a recommendation for its use by an FDA advisory
panel that voted 10-1 in favor of the drug in January.
The approval had been delayed over safety concerns due to serious
and sometimes fatal bleeding in patients who were given the drug in
clinical trials.
 Zontivity is not approved for use in patients who have suffered a
stroke, as those patients were found to be at particularly high risk
of dangerous bleeding.
"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," Ellis Unger, director of the
Office of Drug Evaluation I in the FDA's Center for Drug Evaluation
and Research, said in a statement.
[to top of second column] |
Zontivity works by preventing platelets in the blood from clumping
together and forming clots in the arteries, which can lead to heart
attacks and strokes.
Each year about 190,000 Americans have a second heart-related
event, according to Merck. Zontivity is expected to be used in
addition to standard therapy given to prevent a second heart attack
- typically aspirin and the clot preventer Plavix.
(Reporting by Bill Berkrot; Editing by Mohammad Zargham)
[© 2014 Thomson Reuters. All rights
reserved.] Copyright 2014 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed. |
