FDA Approves New Cholesterol-Lowering Drug

The U. S. Food and Drug Administration approved a new drug for treating high cholesterol levels on Thursday. Evolocumab, called Repatha, is made by Amgen and is the second of a new class of lipid-lowering agents that are hitting the market.

Known as PCSK9 inhibitors, these drugs work by suppressing genes that slow down production of cholesterol receptors on the liver. With these medications, more receptors that are free to emerge and act like sponges can soak up LDL cholesterol and lower their levels in the blood.

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Evolocumab was approved first by the European Medicines Agency in July. In the same month, the U.S. FDA approved another drug in the same class, alirocumab (Praluent), made by Sanofi and Regeneron. In studies, both drugs helped to lower cholesterol levels in the blood by 60% more than the amount achieved by statins. The drugs carry labels that say medications should be used first in people with a strong family history of high cholesterol conditions, or in people who have tried and not responded to statin medications.

PCSK9 inhibitors were discovered among a group of people who happened to have genetic mutations that gave them extremely low cholesterol levels. Researchers studied this rare population, and found they did not have any negative health effects from their mutation other than the beneficial effect on their lipids. So drug makers began investigating ways to replicate the condition with a medication.

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Having another drug that can lower cholesterol levels will be a boon to treating heart disease, which remains the leading killer of Americans each year. Keeping cholesterol levels down, in addition to eating a healthy diet and exercising to maintain weight are crucial to lowering the risk of heart events.