The United States Food and Drug Administration (FDA) approved a new cholesterol drug on July 24, Friday that is much more effective than past medications at unclogging arteries of the waxy fat-like substance. This breakthrough medicine provides hope for millions of people who are at risk for heart disease due to high levels of bad cholesterol (LDL). However, the injection treatment has a sky-high price tag of $14,600 per year.
The drug Praluent is manufactured by Sanofi and Regeneron Pharmaceuticals Inc. While it is more effective than cholesterol drugs used for decades, including statin meds introduced over 20 years ago, the cost of $40 per day will stir public debate about the affordability of innovative drugs.
Low-density lipoprotein (LDL) is often called "bad" cholesterol. The revolutionary drug takes a different approach at lowering LDL levels, and could earn billions of dollars in sales.
Over 73 million American adults (about one-third) have high LDL cholesterol levels. Their risk of heart disease is twice as high as the rest of the U.S. population.
The FDA approved Praluent for two groups with high-risk heart issues. They include 8 to 10 million patients with high LDL cholesterol due to genetics, or with a history of symptoms such as chest pain, heart attack, or stroke.
The condition is so common that employers, physicians, and health insurance providers are concerned about how pricey the new injectable drug is. Generic statin pills cost as low as one dime per day, according to CTV News.
Industry analysts had projected the new drug would be $10,000 per year ($27 per day). However, Sanofi executive Dr. Jay Edelberg noted that yearly expenses for heart attack sufferers can be up to $119,000 ($326 daily).
Experts argue that Praluent should be limited to high-risk patients. In addition, more research is needed to determine if the cholesterol drug reduces heart conditions and deaths.
The FDA's Friday decision followed one by the European Commission earlier this week. Repatha, another cholesterol-lowering drug also included in the new class of biotech medications, was approved, according to Uncover California.