Panel Approves Powerful New Cholesterol Drug
A drug that has been found to significantly reduce "bad" cholesterol in clinical trials cleared a big hurdle yesterday when an advisory panel recommended that the Food and Drug Administration (FDA) approve its use.
If the FDA agrees--and usually it follows the recommendations of its expert panels--the drug alirocumab, produced by Sanofi and Regeneron Pharmaceuticals, would be the first new cholesterol-lowering drug in a generation. In clinical trials, people with serious cholesterol problems saw their LDL, or bad cholesterol, drop dramatically. The pharmaceutical companies have asked that the drug be approved to be prescribed to three groups of patients: people with high levels of LDL (levels around 70 are high risk) who cannot lower it with statins, people at very high risk because they have already had a heart attack or have diabetes and cannot get their levels low enough with statins, and people with high levels of cholesterol who cannot tolerate statins.
Definitive proof of the drug's effectiveness in reducing heart attacks and deaths will only be available when large clinical trials are completed in 2017.
The drugs are likely to be expensive — perhaps $10,000 a year — and millions of people are likely to qualify to take them if they are approved for the broader group. Sanofi estimates that 11 million Americans might qualify for a prescription.