SerpApi.Org
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.
WHAT IS LIPFENDRA?
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.
HOW IS THIS PILL DIFFERENT FROM STATINS?
Statins have been the standard treatment for high cholesterol for decades. They lower cholesterol by helping the liver remove more LDL cholesterol from the bloodstream. Lipfendra works differently.
It blocks a protein called PCSK9, which normally causes cholesterol-removing receptors in the liver to break down. By preventing this process, more receptors remain available to clear LDL cholesterol from the blood, leading to a greater reduction in cholesterol levels.
Because the two medicines work through different mechanisms, doctors say they can complement each other.
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.
WHO IS LIKELY TO BENEFIT?
Experts believe the new pill will be particularly useful for people who:
- Continue to have high LDL cholesterol despite taking statins.
- Cannot reach recommended cholesterol targets.
- Prefer taking a tablet instead of regular injections.
- Have inherited forms of high cholesterol.
Doctors say it is not meant to replace statins for everyone but rather to provide another treatment option when statins alone are not enough.
NEW CHOLESTEROL TARGETS
Earlier this year, leading medical organisations, including the American Heart Association (AHA) and the American College of Cardiology (ACC), recommended more aggressive LDL cholesterol goals.
The updated guidance suggests:
- Below 100 mg/dL for people without major heart disease risk factors.
- Below 70 mg/dL for people at high risk.
- Below 55 mg/dL for people who already have heart disease.
For many patients, reaching these targets can be difficult with statins alone, making additional therapies increasingly important.
INJECTION OR PILL: WHAT'S THE DIFFERENCE?
PCSK9 inhibitors are not new medicines.
The first drugs in this class, including Repatha and Praluent, have been available for several years but require injections.
Lipfendra provides similar cholesterol-lowering benefits in a tablet form, which may improve convenience and encourage better adherence to treatment, especially among people who are uncomfortable with injections.
HOW MUCH WILL IT COST?
Merck has priced Lipfendra at $10.50 per day, or approximately $315 for a 30-day supply in the United States.
The company says many patients may pay less depending on their insurance coverage and other assistance programmes.
The approval of Lipfendra marks a significant step forward in cholesterol treatment. By becoming the first oral PCSK9 inhibitor, it gives doctors another effective option for patients who struggle to lower LDL cholesterol despite standard therapy.
While lifestyle changes such as eating a heart-healthy diet, exercising regularly, maintaining a healthy weight and quitting smoking remain the foundation of cholesterol management, medicines like Lipfendra could help more people reach recommended cholesterol levels and lower their risk of heart attack and stroke.
