The Food and Drug Administration has approved a new cholesterol‑lowering pill that could help millions of Americans.
Merck’s Lipfendra, the brand name for the drug enlicitide, belongs to a class of medications known as PCSK9 inhibitors. Until now, these drugs were only available as injections. Lipfendra is a tablet taken once a day and is the first oral PCSK9 inhibitor to win FDA approval.
Health stories
“Treating cholesterol more aggressively or more fully is our best chance to lower the risk for heart disease for millions and millions of Americans,” said Dr. Allen Taylor, chairman for cardiology at MedStar Heart & Vascular Institute. “Whatever your cholesterol number is, it probably should be lower.”
Taylor called the pill a breakthrough in expanding the medication’s reach, letting patients choose between an injectable every two weeks or a daily pill.
“Despite the availability of the injectable drugs, as safe and effective as they are, they’re vastly underutilized,” he said. “More options available for patients will increase the odds that we get more people effectively treated.”
Heart disease remains the leading cause of death in the United States, with high levels of “bad” cholesterol among the biggest risk factors.
“When your cholesterol is too high, your arteries suffer through developing buildups. And those buildups develop over decades to ultimately lead to things like strokes, heart attacks and premature death,” Taylor said. “We know from studies that this class of drugs reduces those risks.”
Lipfendra is meant to be used alongside statin medications, diet and exercise. A pair of clinical trials showed it reduced low-density lipoprotein cholesterol, or “bad cholesterol,” by 56% and 59%, respectively.
The list price is $10.50 per day or $315 for a 30‑day supply. A Merck spokesperson said they expect out‑of‑pocket costs to be lower and it “will be available to patients in a matter of weeks.”
