PFPC Daily - March 17, 2005

FDA rejects Crestor petition

USA TODAY, March 15, 2005

By Julie Appleby

The anti-cholesterol drug Crestor does not pose a greater risk of
muscle damage than other drugs like it, the FDA said Monday,
rejecting an advocacy group's petition to withdraw the drug.

The Food and Drug Administration also said there is no convincing
evidence to support the group's contention that Crestor could cause
serious kidney damage.

The decision is a boost for AstraZeneca (AZN), maker of the drug,
which has been dogged by controversy since it hit the U.S. market in
2003.

But it is a blow to advocacy group Public Citizen, which submitted
its petition a year ago and last week supplemented it with data it
says show Crestor linked to six times as many reports of muscle
damage per million prescriptions than the combined total of all other
cholesterol-lowering drugs called statins.

The FDA rejected those arguments based on its own review of those
adverse-event reports and ongoing clinical trials and safety data
gathered since the drug hit the market. All cholesterol drugs in the
statin class carry some risk of muscle pain and damage, including a
serious condition called rhabdomyolysis, in which muscle cells die
and release toxins into the body.

"The available evidence ... indicates Crestor does not pose a greater
risk ...," the FDA said in a letter to Public Citizen.

The decision was immediately hailed by AstraZeneca. Crestor sales
topped $908 million worldwide last year. AstraZeneca shares closed at
$41.90 Monday, down 22 cents.

"Patient safety is our top priority, and the FDA's rejection of
Public Citizen's petition should reassure the millions of people who
have been unnecessarily alarmed by the allegations," David Brennan,
CEO of AstraZeneca, said in a statement.

Crestor has not only been criticized by Public Citizen but also
attacked in editorials in the British medical journal The Lancet,
which criticized AstraZeneca's marketing efforts. In November, an FDA
scientist told Congress it was one of five drugs that warranted
further safety study, although the FDA later said the scientist's
views did not reflect those of the agency.

AstraZeneca has also received two warning letters from the FDA saying
its ads about Crestor were misleading. In addition, Crestor was the
first new statin drug to hit the market after the cholesterol drug
called Baycol was pulled in 2001 because it caused severe muscle
damage.

Those factors helped raise awareness of the drug and its possible
side effects, which may have led more doctors and patients to report
adverse events in connection with Crestor, the FDA said.

Public Citizen, in its own statement, criticized the FDA for the
decision and said any "post-Baycol" effect on awareness and
side-effect reports would have affected all so-called statin drugs
equally.

The group said the FDA failed to act quickly on other drugs that were
eventually withdrawn, such as Baycol.

"Once again, when faced with concerns about the safety of a drug, the
FDA has sided with the drug company instead of the public," wrote
Sidney Wolfe, a medical doctor and director of Public Citizen's
Health Research Group.