May 8 U.S. health regulators on Thursday
approved a blood clot preventer developed by Merck & Co
for use by patients who have had a heart attack or who suffer
from blockages in the arteries of the legs.
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
Merck will sell the new medicine under the brand name
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.
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
(Reporting by Bill Berkrot; Editing by Mohammad Zargham)