New Cholesterol Medications Coming Soon

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Update August 2015: Praluent (alirocumab) and Repatha (evolocumab) have both been approved by the FDA. See more information here.

If you have high cholesterol you likely take a statin medication (atorvastatin (Lipitor), simvastatin (Zocor), Crestor) to help you manage it. Statins have been the mainstay of treatment for high cholesterol since their initial approval in the late 1980s—and recent data from the National Health and Nutrition Examination Survey (NHANES) shows that approximately 22% of Americans 45 years of age and older now take a statin.

Having high cholesterol can increase your risk of cardiovascular events like heart attack or stroke, so it’s important to take it seriously even if you don’t feel any effects.

You’ve probably also heard about “good” and “bad” cholesterol. Your good cholesterol, high density lipoproteins, is also known as HDL. Your bad cholesterol has a few different parts, with the most common being your triglycerides and low density lipoproteins (also known as LDL).

Statins can work to help lower your total cholesterol, triglycerides, and LDL, while modestly raising your good cholesterol or HDL.

What’s up next in the treatment of high cholesterol? The FDA advisory committee has just recommended the approval of two new experimental cholesterol-lowering medications that work just as well as statins if not better.

What are the names of the two experimental medications?

Are there any advantages to these new drugs?

Yes. These medications are potentially more potent than statins, with fewer side effects.

Are there any disadvantages?

Yes. First, they will be expensive, brand-name-only drugs. The estimated cost of Praluent, depending on the dose, may range from approximately $5000 to $10,000 per year, and Repatha may be around $10,000 per year for both the bi-weekly and once-monthly doses.

In addition, both medications will need to be injected every two to four weeks using devices similar to insulin FlexPens.

Are there any differences between Praluent and Repatha?

Yes. Cost—while both may be very expensive, Praluent may cost as little as half as much based on your dose.

However, Repatha will offer more dosing options. If approved by the FDA, Repatha will be marketed as a 140 mg bi-weekly or 420 mg monthly injection, while Praluent will only be offered as a bi-weekly injection of 75 mg or 150 mg.

Who would benefit from these new cholesterol medications?

You may benefit from Praluent or Repatha if you have experienced side effects from statins such as muscle pain or weakness known as rhabdomyolysis, or if you have the genetic disease known as familial hypercholesterolemia. Familial hypercholesterolemia is characterized by high LDL (bad cholesterol) levels remaining high despite treatment with a statin, and these two new drugs may be more effective.

Does the FDA have to approve these medications based on the advisory committee’s advice?

No. The FDA does not have to approve medications  although they usually will take the recommendations of the committee.

When will these medications be approved?

These new medications are anticipated to be approved later this year—Praluent on July 24, 2015, and Repatha on August 27, 2015.

Want to find out more?

You can get more info from Regeneron on Praluent from their website here, or more info from Amgen on Repatha here.

Drugs featured in this story

Filed under