The Food and Drug Administration has given the green light to a groundbreaking medication known as Lipfendra, a prescription pill set to dramatically decrease cholesterol levels. The approval, announced on Thursday, marks a significant step forward in heart health management.
Pharmaceutical giant Merck is behind the innovation of Lipfendra, which harnesses the power of enlicitide to target and suppress PCSK9, a protein associated with cholesterol management. Remarkably, clinical trials indicate that Lipfendra can cut LDL cholesterol levels by as much as 60%, significantly outperforming the typical 30-50% reduction offered by standard statins.
Previously, medications targeting this pathway were only available via injection, but Merck’s upcoming release of the Lipfendra pill promises a more user-friendly, and possibly less expensive, alternative for those wary of needles.
Who should take Lipfendra?
The typical adult with untreated high cholesterol often sees levels soar past 100. Health guidelines from the American Heart Association and the American College of Cardiology suggest that individuals at moderate risk for heart complications should target an LDL level below 70, whereas those at higher risk aim for levels under 55.
For patients categorized as high-risk whose cholesterol remains stubbornly high despite statin treatment, Lipfendra offers significant hope. Trials involving injectable PCSK9 inhibitors showed a notable 20% reduction in heart attacks, strokes, and mortality related to cardiovascular issues among these high-risk groups.
According to The New York Times, Merck is currently conducting a study to see if Lipfendra has the same effect, which they are confident it will.
Additionally, some patients do not respond well to statins, which can cause muscle pain, weakness and headaches as well as gastrointestinal issues. Clinical trials of Lipfendra saw no difference in side effects between the drug and a placebo, according to The New York Times.
However, one consideration is that the pill, which is a peptide drug, must be taken in the morning, 30 minutes before eating, according to The Washington Post.
How much will Lipfendra cost?
Lipfendra’s list price will be $315 for a 30-day supply, Merck spokeswoman Julie Cunningham told The New York Times. Patients with insurance may pay less.
As to how it compares to similar product prices, injectable drugs that work the same way currently cost $500 to $600 a month.
“This is a game changer,” said Erin Michos, a cardiologist and professor at the Johns Hopkins School of Medicine, to The Washington Post. “I have a number of patients who are anxiously waiting for the oral one. They didn’t want to go on an injection. I have to give them a call and say it’s out now.”