AstraZeneca gets FDA green light

AstraZeneca won US approval 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.

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 totalled $US4.5 billion in 2009. Thomson Pharma consensus forecasts point to sales of $US6.5 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 US 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.

- Reuters