By Toni Clarke
Jan 13 Merck & Co Inc's experimental
blood clot-preventing drug vorapaxar should be approved, based
on "robustly positive" clinical trial results, according to a
preliminary review of the data by the U.S. Food and Drug
The review, posted on the FDA's website on Monday, comes two
days ahead of a meeting of outside medical experts who are
expected to recommend whether it should be approved. The FDA
usually follows the advice of its advisory panels.
The drug, which would be sold under the brand name
Zontivity, is designed to prevent heart-related deaths, cardiac
arrests and strokes in patients who have had a recent heart
attack. It would not be recommended for patients who have
previously had a stroke because of an increased risk of bleeding
in the brain.
Results from a trial known as TRA 2P "are sufficient to
establish the effectiveness of vorapaxar for its proposed
indication," the review found.
The main safety concern with the drug is bleeding, the
review found, though it noted that the rate of fatal bleeding
was low in the population for whom the drug is proposed.
The FDA did not recommend that the company establish a risk
management program, nor did it recommend that the company
conduct additional trials following approval.
Vorapaxar works by preventing blood cells, known as
platelets, from clumping together and forming clots in the
arteries, which can lead to heart attacks. Other anti-platelets
include aspirin and Plavix, which is made by Bristol-Myers
Squibb Co. Merck's drug works in a different way, by
inhibiting a receptor known as PAR-1.
Each year about 525,000 Americans have heart attacks and
about 190,000 have a second heart-related event, according to
Merck. Standard therapy to prevent a second episode often
includes treatment with aspirin and Plavix. Voraxapar would be
given in addition to standard treatment.
During clinical trials, safety monitors found that patients
who had previously had a stroke were at higher risk of bleeding
in the brain and were instructed to stop taking the drug. Merck
then focused its analysis on patients who had had a heart attack
but no stroke.
Merck's shares rose 2.7 percent to $51.21 in early trading,
helped also by news it had initiated its application to market a
drug for patients with advanced melanoma.
The company also said it is pursuing strategic options for
its animal health and consumer businesses and expects to
complete any action this year.