Astrazeneca urges FDA to dismiss Public Citizen petition on Crestor(R)

07/21/04

Company response finds petition inaccurate and misleading

Wilmington, DE, (July 21, 2004) – In a comprehensive, 30-page response sent today to the U.S. Food and Drug Administration (FDA), AstraZeneca stated that Public Citizen's Health Research Group's (HRG) petition to remove CRESTOR® (rosuvastatin calcium) from the market provides no scientific basis, is inaccurate and must be denied.

According to AstraZeneca, the petition submitted by the activist group on March 4, 2004, provides no scientific basis for challenging the FDA's conclusion that CRESTOR is safe and effective. The company's response asserts that HRG has used unscientific information and unsound analysis to support its petition. The response also argues that HRG has disseminated information that has proved to be incorrect. For instance, the petition claims that "a 39 year-old woman, taking only 20 milligrams a day [of CRESTOR], died of rhabdomyolysis and renal insufficiency." An autopsy ultimately determined that the 39 year-old woman died from myocardial infarction with no evidence of rhabdomyolysis and that her death had nothing to do with CRESTOR.

"Cardiovascular disease is the leading cause of death in the U.S., with elevated levels of LDL cholesterol considered to be a major risk factor," said David Brennan, President and CEO of AstraZeneca U.S. "Revised cholesterol guidelines recently issued indicate that statins such as CRESTOR provide an important and necessary treatment option for the millions of patients around the world who struggle to successfully manage their elevated cholesterol levels."

The response also finds that HRG's petition is based upon a number of unverified, unidentified, spontaneous post-approval adverse event reports, all of which have been previously reported to, and evaluated by, the FDA. HRG also ignores any consideration of the benefits of CRESTOR. The benefit-risk profile of CRESTOR is positive, as the FDA found when it approved the drug last year. HRG has offered no evidence to the contrary.

On July 9, 2003, HRG presented its views on CRESTOR at an FDA Advisory Committee meeting, which primarily focused on the 80 mg. dose for which AstraZeneca did not seek marketing approval. Despite HRG's arguments, the Advisory Committee unanimously recommended that CRESTOR be approved and, on August 12, 2003, the FDA agreed. Almost a year later, HRG has simply repackaged these very same unscientific arguments in its petition, adding nothing new to its one sided attack, other than further anecdote and speculation.

In post-marketing experience with CRESTOR involving more than 2 million patients and more than 6.5 million prescriptions worldwide, the safety profile of CRESTOR remains consistent with AstraZeneca's pre-marketing experience as reflected in the CRESTOR prescribing information, and similar to that of all other currently marketed statins. Reports of rhabdomyolysis (severe muscle weakness) have been very rare (<0.01%), occurring in 1 in 10,000 patients.

CRESTOR has been shown to be safe and effective. At the time of FDA approval, the safety of CRESTOR was evaluated in more than 10,000 patients--more than any other marketed statin prior to approval--with more than 1,500 patients treated for at least 2 years. Currently, CRESTOR is approved in more than 60 countries, and more than 40,000 patients are being or have been treated with CRESTOR in clinical trials.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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