FDA approves new oral cholesterol drug Lipfendra

The US Food and Drug Administration (FDA) has just approved a game-changing cholesterol drug, the first of its kind in a class that’s otherwise administered by injection.
Lipfendra, or enlicitide, blocks the PCSK9 protein, which drives cholesterol levels up and increases the risk of cardiovascular disease.

If you’re one of the roughly 25% of people with cholesterol issues who suffers from hypercholesterolemia – elevated levels of low-density lipoprotein (LDL) cholesterol, the so-called “bad” cholesterol in the blood – this could be of particular benefit.

The FDA came to their approval decision after two late-stage trials demonstrated that the daily pill was able to lower LDL in patients with hypercholesterolemia by an average of nearly 60%. Which is, understandably, a very big deal.

Unlike oral statins, which block an enzyme the liver uses to make cholesterol, Lipfendra is a PCSK9 inhibitor that has a much more powerful impact on LDL levels.

The drugmakers Merck say this new pill could work well as an add-on, complementary medicine for those already on statins.

“Seventy percent of those patients treated with those therapies are still not achieving guideline recommended goals. We believe this is the opportunity,” says Merck’s Executive Vice President Brian Foard.

It’s also aimed at those with genetic variants that lead to high cholesterol levels – something that’s incredibly hard to move the needle on through lifestyle and diet changes alone.

It’s worth noting that the large clinical trials also demonstrated that the new drug does not have the same allergy risk that the injectable versions made by other companies do.

“Despite a decade of approved injectable options, an estimated 70% (and more) of eligible high-risk atherosclerotic cardiovascular disease patients remain undertreated; driven by injection aversion, prior authorization burden, and limited specialist access in primary care,” adds RBC Capital Markets analyst Trung Huynh.

Source: Merck