FDA approves new kind of cholesterol pill

The FDA has approved Lipfendra, a new oral PCSK9 inhibitor from Merck designed to lower LDL cholesterol. This medication offers a pill-based alternative to previously injectable treatments for patients with high cholesterol.
Why it matters
This represents a significant advancement in cardiovascular medicine, potentially improving patient compliance and outcomes for those at risk of heart disease.
The Food and Drug Administration on Thursday approved a new cholesterol pill from Merck that works in a different way from statins. The daily pill, called Lipfendra, is known as a PCSK9 inhibitor — a class of powerful cholesterol-lowering medication that had previously only been available as injections. The drug was approved for people with hypercholesterolemia, or high levels of LDL cholesterol, the so-called bad cholesterol. About 1 in 4 adults in the U.S. have high LDL cholesterol, according to the American Heart Association. Too much LDL cholesterol can lead to plaque buildup in the arteries, increasing the risk of heart disease and stroke. In one late-stage clinical trial, Merck found that Lipfendra lowered LDL cholesterol levels by up to 60% after 24 weeks. In a second trial, people with a genetic condition called heterozygous familial hypercholesterolemia — which causes sky-high cholesterol from birth — saw similar reductions.
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