Federal regulators in the US approved the first of a new class of drugs that can sharply lower cholesterol levels, offering a new option for millions of Americans suffering from cardiovascular disease, the nation’s leading killer.
But the drug, Praluent, which analysts project will become a huge seller, is expected to become the next flashpoint in the growing controversy of escalating pharmaceutical prices, and health plans are expected to put in place strict measures to control which patients can use the drug and prevent it from becoming a budget-buster.
In clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 per cent or more, even among patients already taking statins, the mainstay pills like Lipitor for controlling blood lipids. Some cardiologists say Praluent and similar drugs in the pipeline represent significant advances.
Praluent, also known as alirocumab, was endorsed last month by outside advisers to the Food and Drug Administration. So was Repatha, or evolocumab, a similar drug developed by Amgen that is expected to win FDA approval by the end of August.
But there was considerable debate among the advisers as to how broadly the drugs should be used. The FDA finally approved Praluent for patients who have had a history of heart attacks, strokes, chest pain or related conditions, or have a genetic condition that causes high cholesterol and who require additional lowering of LDL, despite taking the highest dose of a statin they can tolerate.
Studies aimed at showing that the drugs prevent heart attacks and strokes are underway, but results are not expected until around 2017. Some doctors say they will use the drugs sparingly or not at all until then.