Is the new cholesterol pill for me?

On July 16, the FDA approved enlicitide (brand name Lipfendra) to lower LDL cholesterol in people with high cholesterol. For people with very high cholesterol, this is a big deal.

We have known since the late 1950’s that elevated cholesterol was associated with an increased risk of heart attack, but the drugs then available to lower cholesterol were not very effective and had very annoying side-effects.

The first statin, lovastatin, was approved by the FDA in 1987 and it was a real “game changer.” There was finally a class of medicines that were well-tolerated by most people and very effective at lowering cholesterol. In 2026, seven statins are commercially available, most now available generically and thus reasonably priced. The evidence that these drugs not only reduce cholesterol but also reduce heart attack risk is overwhelming.

A minority of patients at risk from high cholesterol cannot take statins, usually because of an allergy that leads to liver damage. Some people take them safely but do not get adequate cholesterol lowering, even at high doses. The non-statin cholesterol-lowering drugs (ezetimibe, bempedoic acid) are not nearly as effective as statins and are usually added to a statin rather than used alone.

A true breakthrough was the development of what are called PCSK9 inhibitors, a totally new class of drugs that are very powerful at lowering cholesterol and which have now also been shown to reduce heart attack risk. These can be safely used in people who cannot take statins, though they are most often used as add-ons to statins in patients who have not reached desired cholesterol levels on the statin.

The two big downsides to PCSK9 inhibitors are that they are VERY expensive (list price around $6000/year) and that they must be given by injection.

The new drug enlicitide also works by inhibiting PCSK9 but comes in pill form, taken once daily. It will not be cheap; estimated list price is $3800/year.

Who should consider taking this new drug? If you cannot take a statin and you need to get your cholesterol down, or if you are on a full dose of a statin but you have not reached the cholesterol goal you set with your doctor, you are a candidate for a PCSK9 drug. If you would rather take a daily pill than an injection, enlicitide may be the answer.

Since safe, effective and cheap statins are the right choice for most people with high cholesterol, expect your insurance company to balk at paying for a much more expensive drug. If you need one, your doctor will have to convince them that you do.


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