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.
But the prospect of introducing highly-expensive, injectable drugs for one of the most common medical conditions is drawing concerns from health insurers, doctors and employers. Especially since generic statin pills are now available for as little as a dime a day.
More than 73 million U.S. adults have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death worldwide.
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 attack, stroke, chest pain and related conditions.