FDA approves new daily pill to lower bad cholesterol

People living with high cholesterol may soon have a new treatment option that does not involve injections. The US Food and Drug Administration (FDA) has approved Lipfendra, a once-daily pill developed by Merck that belongs to a powerful class of cholesterol-lowering medicines called PCSK9 inhibitors.

Until now, PCSK9 inhibitors were available only as injections. With Lipfendra, patients who need stronger cholesterol control now have an oral option that could make long-term treatment easier and more convenient.

The approval is especially important for people whose LDL cholesterol, often called "bad" cholesterol, remains high even after taking statins. Clinical trials showed that the new pill reduced LDL cholesterol by up to 60% over 24 weeks, offering another weapon against heart disease and stroke.

Lipfendra is a prescription medicine approved for adults with hypercholesterolaemia, a condition in which LDL cholesterol levels are higher than normal.

LDL cholesterol is known as "bad" cholesterol because excess amounts can



build up inside blood vessels, forming plaques that narrow the arteries. Over time, this increases the risk of:

. Heart attack

. Stroke

. Coronary artery disease

. Other cardiovascular problems

According to the American Heart Association, about one in four adults in the United States has high LDL cholesterol.

CLINICAL TRIALS SHOWED UP TO 60% REDUCTION

Merck tested Lipfendra in two late-stage clinical trials.

The studies found that:

. LDL cholesterol fell by up to 60% after 24 weeks.

. Patients with heterozygous familial hypercholesterolaemia, an inherited condition that causes very high cholesterol from birth, also experienced significant reductions.

. Most participants were already taking statins, and many were also receiving another cholesterol-lowering medicine called ezetimibe.

This suggests that Lipfendra can provide additional cholesterol reduction when added to existing treatment.