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Repatha joins Sanofi Regeneron’s Praluent, approved last month, a similar drug that costs $14,600 per year. So potent are these new drugs that they give rise to a question that has rarely been asked: How low should a person’s cholesterol go?

The two companies have arrived at very different answers.

Amgen scientists say the lower the better, and the company offers just one dose of Repatha — the maximum dose. Sanofi offers two doses of Praluent; the lower dose is half the maximum one.

Patients taking Praluent are to begin with the lower dose and stop there if cholesterol declines enough, in a doctor’s judgment.

Both drugs are antibodies that inactivate a gene called PCSK9. In studies of large populations, academic researchers discovered that people whose PCSK9 genes were naturally less active or completely inactive had very low levels of LDL cholesterol and were protected from heart disease.

Drug companies seized upon the finding and began developing PCSK9 inhibitors with record speed. But company scientists realized it would not be enough to show that the drugs slash LDL levels. They would also have to conduct huge clinical trials to show these drugs prevent heart attacks and strokes.

Those studies are still underway, but the F.D.A approved Repatha and Praluent anyway for people at high risk."

http://www.nytimes.com/2015/08/28/health/fda-approves-another-in-a-new-class-of-cholesterol-drugs.html?ref=health&_r=0