Archive · 20 Jul 2026
FDA Approves New Once-Daily Cholesterol-Lowering Pill
The FDA has approved a new pill called Lipfendra to help lower bad cholesterol in adults.
This pill is taken once a day and works by blocking a protein called PCSK9, which helps the liver clear bad cholesterol from the blood.
In clinical trials, Lipfendra reduced bad cholesterol by about 56%-59% in people who already had high cholesterol.
The most common side effects were diarrhea and dizziness.
Doctors say this new medication can be a good addition to other treatments and lifestyle changes for people who have high cholesterol and are at risk of heart disease.
However, they also mention that more long-term studies are needed to see how well it prevents heart attacks and strokes.
FDA approves Lipfendra, a once-daily oral tablet to lower LDL cholesterol in adults with high cholesterol and HeFH.
Lipfendra is the first oral medication to block PCSK9, a protein that reduces the liver's ability to clear LDL cholesterol.
Clinical trials showed a 56%-59% reduction in LDL cholesterol in participants already on maximally tolerated statin therapy.
Common side effects include diarrhea and dizziness, with an overall safety profile similar to placebo.
Experts recommend Lipfendra as an adjunct treatment alongside a heart-healthy diet, regular physical activity, and other standard treatments.
- Who
- Adults with high cholesterol and HeFH
- What
- FDA approval of Lipfendra, a new once-daily pill to lower LDL cholesterol
- When
- Recently approved by the FDA
- Where
- United States
- Why
- To provide a new oral treatment option for lowering LDL cholesterol and reducing cardiovascular risk
Optimistic View
Cautious View
Effectiveness
Optimistic View
The significant reduction in LDL cholesterol (56%-59%) is very promising and can greatly reduce cardiovascular risk.
Cautious View
While the cholesterol reduction is encouraging, long-term studies are needed to confirm the impact on cardiovascular events.
- Medication Name
- Lipfendra (enlicitide)
- Approval Authority
- FDA
- Target Condition
- High cholesterol and heterozygous familial hypercholesterolemia (HeFH)
- Mechanism
- Blocks PCSK9 protein to help liver clear LDL cholesterol
- Common Side Effects
- Diarrhea and dizziness
- Clinical Trial Participants
- 3,207 adults with severe hypercholesterolemia
- LDL Reduction
- 56%-59% reduction in LDL cholesterol
- Usage
- Once-daily oral tablet