NEW YORK (Reuters) — 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 found.
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 decision.
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.
(Reporting by Ransdell Pierson in New
York; additional reporting Ludwig Burger in Frankfurt; editing by
Alden Bentley and Nick Zieminski)
