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The US Food and Drug Administration approved enlicitide, marketed by Merck as Lipfendra, as a once-daily tablet for lowering low-density lipoprotein cholesterol (LDL-C), according to reporting by Gina Kolata in The New York Times on July 16, 2026. The drug inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), the same target as the injectable antibodies already on the market, and it is the first agent in that class to reach patients as a pill.
Merck reported results last November from a 24-week trial involving 2,912 participants, in which the drug lowered LDL-C by up to 60%, with no difference in side effects between the drug and placebo. Those figures match what has been seen with the injectables. Trial participants achieved LDL-C levels of 50-60 mg/dL or lower. Adults taking no lipid-lowering therapy generally run above 100 mg/dL. Guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC) call for LDL-C below 70 mg/dL in patients at above-average risk of heart attack or stroke, and below 55 mg/dL in patients at high risk, such as those with a prior myocardial infarction.
The key statistic for those managing pharmacy benefits is not the LDL-C reduction but rather that only 1% of the 6 million patients eligible for injectable PCSK9 inhibitors actually utilize them, despite evidence suggesting that this class reduces heart attack risk by 20% in high-risk patients. According to a report by Kolata, the injectables have list prices ranging from $500 to $600 a month and higher, which can lead to hesitance from insurers regarding payment, and some patients may prefer not to receive injections. Each of these three barriers exists within the coverage pathway or at the point of administration.
Lipfendra lists at $315 for a 30-day supply, or $10.50 a day, and Merck said it will be available in a few weeks. The pill also changes where the product lives. A retail tablet dispensed at the corner pharmacy is a different animal from a specialty injectable routed through a specialty pharmacy channel, and it moves the coverage question toward standard formulary placement and tier assignment. Dr. Dean Li, president of Merck Research Laboratories, said the company wants lowering cholesterol with Lipfendra to be as easy and convenient as it is with a statin, and noted that primary care physicians can prescribe it rather than limiting it to cardiologists. Most patients at risk of a heart attack are already taking a blood pressure medication, a statin, and aspirin.
Cardiologists unaffiliated with Merck welcomed both the approval and the price. Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston who consults for several other drug companies, said he was thrilled. Dr. David Maron, a preventive cardiologist at Stanford, said the cost difference relative to the injectables would matter.
Outcomes evidence for the pill is not yet in hand. Studies of the injectables showed a 20% reduction in heart attacks, strokes, and cardiovascular deaths in high-risk patients, and Merck has a study underway to learn whether Lipfendra does the same. Dr. Li said he is confident it will. Whether the makers of the injectable PCSK9 inhibitors cut their prices in response is not yet clear.
