A new pill could soon reset the bar for how low cholesterol can go. The FDA has cleared Merck's once-a-day drug enlicitide, sold as Lipfendra, which in trials pushed "bad" LDL cholesterol down to around 50 or 60—well below what most statins typically achieve, per the New York Times. The pill targets the PCSK9 protein, the same pathway used by current injectable drugs, but in pill form and at a lower list price: $315 for a 30-day supply, versus $500 to $600 or more per month for injections.
Reuters notes that high LDL levels, which afflict about 25% of US adults, can lead to plaque buildup in the arteries. In a 24-week trial of nearly 3,000 people, Lipfendra cut LDL by up to 60%, with side effects similar to those from a placebo, per the Times. "This is a pivotal moment as we bring the first US FDA-approved oral PCSK9 inhibitor to adults with high LDL-C, offering patients an important new option," Dr. Dean Y. Li, president of Merck Research Laboratories, says in a release.
Cardiology groups now urge many patients at elevated risk of heart attack or stroke to get their LDL below 70, and below 55 for those at very high risk—targets that most Americans don't hit without help, per the Times. Only about 1% of the roughly 6 million people eligible for PCSK9 inhibitors currently use the injectable versions, hampered by cost, insurance hurdles, and needle aversion. A large outcomes study is underway to confirm whether the pill, like its injectable cousins, can trim heart attack and stroke risk in high-risk individuals by about 20%.
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