UPDATED: Sanofi/Regeneron's PCSK9 blockbuster-in-waiting gets prelim FDA nod
- An external review group voted Tuesday to recommend the FDA approve Praluent (alirocumab), part of a blockuster new class of anti-cholesterol agents.
- The other drug in this class, Repatha (evolocumab), will be considered by the panel Wednesday.
- If the drugs ultimately receive FDA approval, they will offer a powerful new treatment option for millions of people with high cholesterol, and would bring billions in sales to Sanofi and Regeneron (which back Praluent) and Amgen (which backs Repatha).
The review group voted 13-3 Tuesday to recommend full FDA approval of Praluent, which could offer new hope to patients who are not responding well to traditional statin treatment for high cholesterol. By some estimates, 11 million people might be candidates for the therapy, at a cost that could approach $10,000 per person per year. That's $110 billion in potential sales -- and even if the drugs are sold at lower prices to far fewer people, they would be multi-billion-dollar blockbuster sellers.
Early indications are that they could be remarkably effective. Tests indicate the drugs can drop LDL cholesterol levels by about 60 percent with few side effects and excellent overall tolerance.
However, on the other side, there is the concern that by approving a new class of drugs targeted at patients, who are statin intolerant (as well as other population), FDA officials could unintentionally lead patients and physicians to prematurely abandon statins, a time-tested and effective class of drugs. Large clinical trials of the drugs are now underway.