Crestor (rosuvastatin), the 'superstatin' for cholesterol-lowering developed by AstraZeneca, has been recommended for approval by a US Food and Drug Administration advisory panel. The news improves the drug's chances of getting onto the important US market without restrictions on its dose range.
AstraZeneca applied to the FDA to market Crestor in doses ranging from 5mg to 40mg, having decided to drop a higher 80mg dose in the wake of the safety scare over statins, which led to the withdrawal of Bayer's Baycol/Lipobay (cerivastatin) in 2001.
The late-stage development of Crestor has been dogged by suggestions that it may have a tendency to cause the same myopathy side effect that led to Baycol's demise. Just as this concern was largely laid to rest, an FDA document, published just ahead of the panel meeting, also pointed to kidney side effects at the 40mg dose.
In the end, the panel recommended that Crestor should be approved across its entire dose range, with the proviso that those on the 40mg dose should be monitored for kidney function. It was also suggested at the meeting that 40mg was not significantly better than the safer, 20mg dose. The FDA now has until August 12 to deliver its verdict on the application.
Analysts are divided over the prospects for Crestor, but on the whole agree that it is likely to become a blockbuster drug, despite the safety concerns. Peak sales forecasts are in the $2 to $3 billion (€1.76-€2.65bn) range.