AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has formally denied Public Citizen's Health Research Group's (HRG) petition to remove CRESTOR(r) (rosuvastatin calcium) from the market. The FDA's rejection of HRG's petition was based on a thorough analysis of clinical trial safety data and post-marketing data.
"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 HRG's allegations," said David Brennan, President and CEO of AstraZeneca U.S.
The response letter from the FDA stated that all of the available evidence indicates that CRESTOR does not pose a risk of muscle toxicity greater than the other approved statins, and that with respect to renal toxicity, there is no convincing evidence that CRESTOR poses a serious risk of renal injury.
"CRESTOR is an important treatment option for patients who are unable to achieve their cholesterol goals with diet and exercise alone," said James Blasetto, MD, Executive Director, Strategic Development, CRESTOR.
Recently the FDA approved revisions to the CRESTOR prescribing information, which strengthened language around the appropriate use of CRESTOR. At the same time, the FDA issued a statement confirming that the potential benefits of CRESTOR outweigh the potential risks when taken as directed.
At the time of FDA approval, the safety of CRESTOR was evaluated in more than 12,000 patients - more than any other marketed statin prior to approval - with more than 1,500 patients treated for at least two years. CRESTOR was unanimously recommended for approval by an FDA advisory board in July 2003.
CRESTOR is now approved in more than 70 countries, has been prescribed over 18 million times for more than 4.3 million patients and has been studied in clinical trials of more than 50,000 patients.