WASHINGTON — The Food and Drug Administration on Friday approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades.
The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease. But the drug’s sky-high price tag — $14,600 per year — is certain to escalate debate about the cost of breakthrough drugs and who should take them.
Praluent is the first in a new class of biotech medications that use a novel approach to lower bad, or LDL, cholesterol. The drugs are considered the first major advance in treatment since the introduction of statin drugs more than 20 years ago, and analysts expect them to generate billions in sales.
The FDA approved Praluent for two groups of patients at highest risk of heart problems:
• Patients with abnormally high LDL cholesterol caused by an inherited condition;
• Patients with high LDL cholesterol and a history of heart attacks, strokes, chest pains and related conditions.
