OR WAIT null SECS
AstraZeneca caused a ruckus at the American Heart Association's annual meeting as data was released proving that its statin not only works for its target indication, but also reduced major CV events in patients who don?t have high cholesterol.
AstraZeneca’s blockbuster statin Crestor (rosuvastatin) got a huge boost on Sunday with news that the treatment helped decrease risk of major cardiovascular events by 44 percent in a clinical trial of nearly 18,000 men and women.
The study-dubbed Jupiter-was designed to determine the impact of Crestor on cardiovascular events in a population of patients that do not have elevated cholesterol, but have elevated C-reactive protein or CRP. Before a packed audience at Sunday’s meeting of the American Heart Association, investigators released their findings, which include:
Decision Resources senior analyst Nikhil Mehta told Pharm Exec that this was a huge study for AZ because it should yield Crestor’s first approval for preventing cardiovascular outcomes. “That was a major weakness for the drug before Jupiter,” Mehta said. “All the other statins that are available in the Western market have outcomes data. The trial itself answers important questions of Crestor’s safety and efficacy, but it also poses new questions that need to be followed up in future research.”
Those questions include reports of a small spike in diabetes cases found in patients taking Crestor. But Mehta noted that the diagnosis has been seen in other statin trials.
“I think the data and the media response to the data is going to be positive," Mehta said. “Because the CRP test is commercially available, some clinicians might be tempted to start using it a lot more and prescribing Crestor or another statin therapy to their patients.”
Other statins that lower CRP include Zocor (simvastatin ) and Lipitor (atorvastatin), which is losing exclusivity in 2011. AstraZeneca made it clear, however, that this trial was for Crestor alone. “The Jupiter trial was with Crestor therapy; other drugs were not studied in this category of patients, and it cannot be extrapolated to other statins as a result,” said James Blasetto, VP strategic development at AZ. “We can only speak to the results demonstrated for Crestor.”
AstraZeneca CEO David Brennan downplayed the potential boost in sales, telling TheWall Street Journal, “We’ve seen a flurry of estimates from analysts about the commercial impact of [the study], some of them pretty bullish. I would urge caution when forecasting the speed of such changes.”
AZ plans to file a regulatory submission in hope of having a labeling change by the first half of 2009.