FDA approves first daily pill to drastically lower cholesterol levels

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Federal regulators approved a first-of-its-kind cholesterol medication from Merck that rivals the effectiveness of powerful drugs already on the market.

The Food and Drug Administration (FDA) greenlighted the once-daily pill called Lipfendra, which reduces “bad” or low-density lipoprotein cholesterol (LDL-C) in adults by inhibiting the production of PCSK9 proteins.

Lipfendra is the first drug that is taken by mouth that blocks PCSK9, a protein that plays a vital role in regulating cholesterol levels. Injectable versions of PCSK9 inhibitors have been on the market for several years but are much more expensive.

Clinical trials showed the medicine slashed levels of artery-clogging plaque by more than 56 percent compared to placebo.

Over time, excess LDL-C penetrates the lining of your arteries. Together with inflammatory cells, it becomes trapped inside the artery walls, forming plaques. If a plaque ruptures, it can trigger a blood clot, potentially leading to serious health problems such as heart attack or stroke.

Guidelines issued by the American Heart Association and the American College of Cardiology recommend that people who have an above-average risk of heart attacks or strokes should get their LDL levels below 70. Adults with high cholesterol not taking medication have LDL levels around 100.

There are many options already available to treat high cholesterol, including statins, ezetimibe, and PCSK9 inhibitors. Statins like Lipitor are widely used and considered the gold standard in cholesterol treatment. However, they don’t always work for every patient.

PCSK9 injectables are used in high-risk patients when statins and lifestyle changes in diet and exercise have not sufficiently lowered LDL levels.

The list price for Lipfendra will be $10.50 per day, based on a 30-day supply. Merck said it expects out-of-pocket costs to be lower than the list price for many patients regardless of their insurance, including the majority of Medicare patients who have coinsurance requirements.

Injections can cost upwards of $500 per month.

Merck said it also plans to make Lipfendra available at a discounted cash price through trumprx.gov, the administration’s website offering cash discounts on certain prescription drugs. Merck hasn’t set the price for TrumpRx yet.

The company said it will offer a coupon program that reduces out-of-pocket costs.

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