By Toni Clarke
WASHINGTON Jan 16 Johnson & Johnson's
anticoagulant Xarelto should not be approved to prevent further
heart problems in patients who have recently suffered a heart
attack, an advisory panel to the U.S. Food and Drug
Administration concluded on Thursday.
The panel voted 10 to 0, with one abstention, that data
presented by the company from a single clinical trial was not
strong enough to justify approval, especially since some data
from was missing.
The FDA is not bound to follow the advice of its advisory
panels but typically does so.
Xarelto is already used to treat and prevent deep vein
thrombosis and pulmonary embolisms and to reduce the risk of
stroke and blood clots in patients with an irregular heart beat
that is not caused by heart problems.
The company had hoped to also win approved for its use in
patients with acute coronary syndrome (ACS), an umbrella term
covering any condition brought on by a sudden, reduced blood
flow to the heart, including heart attack and chest pain.
The vote follows a negative review from staff at the FDA
whose report, published on Tuesday, noted that there was no
proof the drug confers significant benefit.
Dr. Paul Burton, vice president of clinical development at
Janssen Research and Development, a J&J unit, said in a
statement that the company will "work with the FDA to address
questions raised today."
J&J originally filed for approval of Xarelto in ACS at the
end of 2011. The FDA rejected the application, citing missing
data, and said the trial results were not strong enough to
support approval. The company retrieved some missing data but
the FDA once again declined to approve the drug, prompting J&J
to appeal the decision.
The FDA denied the appeal but said limiting the duration of
use to one month might be a pathway forward because efficacy was
more evident and the risk of bleeding, a side effect of the
drug, was lower during this period. J&J filed a new application
seeking a treatment duration of 90 days.
Panelists said the inclusion of J&J's additional data did
not alter their view that the benefit of the drug was not shown
to outweigh an increased risk of bleeding.
Neither did they think it was possible to carve out a 90-day
time frame from the overall clinical data and make definitive
conclusions about the drug's safety or efficacy.
"Looking at the overall study it wasn't robust enough in
terms of statistical significance to be considered a positive
study, and with that it was not possible to look at subgroups,"
said Dr. Philip Sager, consulting professor of medicine at
Stanford University School of Medicine.
Dr. Stephen Grant, deputy director of the FDA's division of
cardiovascular and renal drugs, said the benefit of the drug met
the criteria required to approve a drug based on a single trial
- namely, proof it was superior in some way to existing