* FDA approves Crestor for preventing heart disease
* Approval likely to boost sales
(Adds FDA, company comments)
By Lisa Richwine
WASHINGTON, Feb 8 (Reuters) - AstraZeneca won U.S. approval
on Monday to promote cholesterol fighter Crestor for preventing
heart disease in a vast new market of people with healthy
cholesterol but other heart risks.
The Food and Drug Administration cleared Crestor for a
group of people numbering in the millions who are not typically
prescribed cholesterol drugs now.
Crestor won FDA approval for reducing the risk of heart
attacks, strokes, bypass operations and artery-clearing
procedures in people with high levels of C-reactive protein
(CRP) plus at least one other risk factor.
CRP is a sign of inflammation associated with heart
disease. Patients should be men at least 50 years old or women
at least 60, the FDA said.
The approval was based on data from a nearly 18,000-patient
study funded by AstraZeneca and called Jupiter.
The study tested Crestor versus a placebo in middle-aged
people with healthy cholesterol, but high CRP. The rate of
major cardiovascular problems was 1.6 percent for patients
treated with Crestor compared with 2.8 percent with a placebo,
the FDA said.
An FDA advisory panel that reviewed the Jupiter results in
December backed wider use but voiced concern that doctors might
use Crestor too broadly in patients with low risk. FDA
reviewers had told the panel up to 6.5 million Americans meet
the criteria used in the Jupiter study.
On Monday, the FDA said doctors "must interpret the results
of the Jupiter trial with caution." The findings "do not
support the use of Crestor in all patients with elevated
(CRP)," the agency said.
For example, there was no evidence Crestor helped patients
with high CRP but no traditional risk factors such as high
blood pressure, low HDL or "good" cholesterol, smoking or a
family history of early heart disease, the FDA said.
Wider approval for Crestor is likely to boost sales of the
drug, but industry analysts say the size of the opportunity is
uncertain because of the looming arrival of cheaper generic
versions of Pfizer Inc's rival Lipitor in late 2011.
AstraZeneca's global sales of Crestor totaled $4.5 billion
in 2009. Thomson Pharma consensus forecasts point to sales of
$6.5 billion in 2013, when it will be the Anglo-Swedish
company's biggest seller by far. Crestor is a main driver for
the company as sales of older medicines fall away. But the
drug's future is under a cloud due to challenges to the U.S.
patent that AstraZeneca will defend at trial later this month.
Both Crestor and Lipitor are part of the family of
cholesterol-lowering drugs called statins that are already
prescribed to millions of people.
Statins typically are prescribed to lower high cholesterol,
a risk factor for heart disease, which remains the leading
killer in the United States.
But more than half of patients who suffer heart attacks or
other cardiovascular problems have normal cholesterol levels.
That led AstraZeneca to search for other groups that could
benefit from Crestor.
"Not only is this approval a significant milestone for
AstraZeneca, but it is also important for the patients who
could now benefit from Crestor therapy under this approved
indication," AstraZeneca Chief Medical Officer Howard
Hutchinson said in a statement.
Complications in the Jupiter study were similar to known
risks of statins and included muscle pain, the FDA said.
The agency noted an "unexpected" increase in diabetes in
Crestor patients, but said previous research has "suggested
this is an effect of all statin drugs and not unique to
Crestor."
The drug's generic name is rosuvastatin.
(Reporting by Lisa Richwine; editing by Carol Bishopric,
Leslie Gevirtz)
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