By Ransdell Pierson
NEW YORK Feb 14 U.S. health regulators have
again declined to approve proposed wider uses of Bayer AG
and Johnson & Johnson's lucrative blood clot
preventer Xarelto, the drugmakers said on Friday.
The companies had sought approval from the U.S. Food and
Drug Administration (FDA) to market the blockbuster pill for
prevention of new heart attacks and strokes, and death, in
patients with acute coronary syndrome (ACS), and also to prevent
clogging of heart stents.
ACS is an umbrella term covering any condition brought on
by sudden reduced blood flow to the heart, including heart
attack and chest pain.
Xarelto's biggest current approved use is to prevent blood
clots and strokes in patients with an irregular heartbeat called
atrial fibrillation. The condition occurs mainly in the elderly.
An advisory panel to the FDA concluded in January that
Xarelto should not be approved to prevent new heart attacks or
strokes, a use referred to as secondary prevention.
The medicine is co-marketed by J&J and Bayer.
Clinical data from a single J&J trial was not strong enough
to justify approval to market Xarelto to prevent further heart
problems, especially since some data was missing, the panel
J&J originally filed for approval of Xarelto in ACS in late
2011. The FDA rejected the application, citing missing data. The
company retrieved some missing data but the FDA once again
declined to approve the drug, prompting J&J to appeal the
After the FDA denied the appeal, J&J filed a revised
marketing application. But panelists in January said the
additional data did not alter their view that the benefit of the
drug was not shown to outweigh an increased risk of bleeding.
Johnson & Johnson spokeswoman Kristina Chang on Friday
declined to comment when asked if the FDA, in its rejection, had
asked for new clinical trials to be conducted for the requested
new uses or asked for other information.
"We are not disclosing the details because we still are
evaluating the contents and our next steps," Chang said.
Shares of J&J were down 0.5 percent in morning trading on
the New York Stock Exchange, while shares of Bayer rose 0.86
percent in Germany.