The U.S. Food and Drug Administration has approved a new once-daily pill that can reduce LDL, commonly known as “bad” cholesterol, by nearly 60%.
The drug, enlicitide, will be marketed as Lipfendra and is manufactured by Merck. It is intended mainly for patients with high LDL cholesterol, including those with heterozygous familial hypercholesterolemia, an inherited condition that causes elevated cholesterol from birth.
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Lipfendra is the first approved oral medication in the PCSK9 inhibitor class. These drugs block a protein that limits the liver’s ability to remove LDL cholesterol from the bloodstream.
Until now, PCSK9 inhibitors such as Repatha and Praluent have been available only as injections. Lipfendra is expected to cost $315 for a 30-day supply and reach U.S. pharmacies within weeks.
Unlike statins, which can generally be taken at any time, the new pill must be taken in the morning on an empty stomach with a small amount of water, black coffee or tea. In the United States, primary care physicians will be able to prescribe it without requiring a cardiologist.
Clinical trials lasting 24 weeks included nearly 3,000 participants and found LDL reductions of up to 60%. Similar results were recorded among patients with inherited high cholesterol. The overall rate of side effects was comparable to that seen with a placebo.
Merck said the drug did not produce the muscle pain sometimes associated with statins. However, Lipfendra was tested mainly as an additional treatment for patients already receiving the maximum statin dose they could tolerate, rather than as a replacement for standard therapy.
PCSK9 inhibitors may also reduce lipoprotein(a), or Lp(a), an inherited cholesterol-carrying particle linked independently to a higher risk of heart attack and stroke. Statins generally do not lower its level.
Israeli patients played a significant role in the Phase 3 research. A total of 163 participants were enrolled at 14 medical centers across Israel.
Prof. Yaakov Henkin of Soroka Medical Center and Ben-Gurion University, who led the Israeli arm of the trial, said the drug allows liver receptors to identify and remove more LDL cholesterol from the blood.
“The results show a significant decline in bad cholesterol without significant side effects, which should support better adherence to treatment over time,” he said.
Dr. Dov Gavish of Wolfson Medical Center said the pill’s accessibility could make a major difference for patients who are reluctant to use injections.
“The fact that this is a pill rather than an injection makes the treatment much more accessible,” he said. “It is an important step in preventing cardiovascular disease.”