AstraZeneca scored a 'yes' vote at yesterday's FDA advisory panel meeting. The agency's expert advisors recommended the company's cholesterol drug Crestor for broader use--much broader use. If the agency ratifies that decision, Crestor could be marketed to folks who don't even have high cholesterol levels. As many as 6 million more people would fit the drug's new labeling, the Los Angeles Times reports.
Crestor is a statin, and research suggests that statins don't just work on cholesterol levels. In Crestor's case, the operative action is reduction of inflammation; the type that's implicated in cardiovascular disease comes along with increased levels of C-reactive protein (CRP). If AstraZeneca could prove that Crestor helped patients with high CRP levels, it stood to reason that it might capture a whole new market.
So, AstraZeneca studied Crestor in patients with high CRP levels but normal-to-slightly-elevated cholesterol, finding that the drug cut the risk of death from heart disease by 20 percent. The results were so overwhelming, that the four-year study was cut off after two years. That was the much-reported JUPITER study, and it's the data AstraZeneca wants summarized on Crestor's label, allowing it to market the drug to patients with high CRP.
- read the AstraZeneca release
- see the story in the Wall Street Journal
- check out the LA Times piece