Panel Approves New Drug for Tough Cholesterol Cases

Injection-300x200.jpgAging parents, take note: an advisory panel for the U.S. Food and Drug Administration (FDA) has voted to recomm​end approval of alirocumab, a new drug intended to help lower high levels of bad cholesterol.

If granted final approval by the FDA, another option may be available, especially for individuals who are unable to lower cholesterol using currently approved treatments.

Bad cholesterol

There are two types of cholesterol; the one for which alirocumab was developed to treat is low-density lipoprotein (LDL), commonly called "bad cholesterol." Somewhere around 73 million people in the United States have LDL, although about half of these individuals are not currently taking medication to treat the problem. Those who are on medication are typically prescribed the class of drugs known as statins. Lowering LDL is important because high levels are associated with greatly increased risk of heart disease.


Statins have been the "go to" treatment for lowering high LDL for more than 20 years; however, no drug is 100% effective in all individuals, and that is the case with statins. People with the genetic disorder known as familial hypercholesterolemia, which is accompanied by often dangerously high levels of LDL, tend to not respond well to statins. Other groups of people, including aging parents and others with diabetes or previous history of heart attack, often find that statins do not sufficiently lower LDL levels. In addition, some people simply experience statin-related side effects that make continued use of the treatment difficult.


The new drug works by decreasing the effects of something known as PCSK9, which tends to dampen the liver's effectiveness in removing cholesterol from the blood. If the PCCSK9 is repressed, the liver can do a better job of cleansing and LDL levels will fall.

Although the panel voted 13-3 in favor of recommending approval, there is considerable disagreement among the panel members as to how widely used alirocumab should be. Many of the panelists believe its use should be restricted, largely recommending it be used on patients who have very high LDL and are unable to achieve reductions through the use of statins.

If the FDA does follow the panel's recommendation and grant approval to the drug, the agency will then decide how widely available alirocumab should be.

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