An FDA reviewer has backed AstraZeneca's request for broadened Crestor use, saying that the statin's benefits outweigh potential risks. You'll recall that last year AstraZeneca released results from the 18,000-patient JUPITER trial in which Crestor proved dramatically effective at cutting the risk of heart attack and death among patients who seemed healthy but showed high levels of C-reactive protein, or CRP.
Risks posed by the statin's use include a greater chance of developing diabetes. And in the JUPITER trial, there were 13 deaths due to gastrointestinal disorders, as compared with just one in the placebo group. In addition, more patients on the drug experienced a confusional state. The reviewer said the diabetes issue needs further study, but that the gastro-related fatalities could have been a chance finding. The comments are part of materials the FDA released in advance of an advisory committee's meeting next Tuesday, when the expert panel will decide whether to recommend expanded Crestor use. AstraZeneca filed an sNDA for the drug in July.
- read the FDA and AstraZeneca's pre-meeting briefing materials
- check out this article
- read the Dow Jones report for more