FDA Approves New Daily Pill for Lowering Bad Cholesterol with Israeli Clinical Trial Participation
The U.S. Food and Drug Administration (FDA) approved a new daily pill called Enlicitide, marketed as Lipfendra by Merck, which significantly reduces LDL cholesterol levels. This medication, developed through a clinical trial that included 163 Israeli participants across 14 medical centers, targets patients with hypercholesterolemia, a condition affecting one in four adults in the West. Lipfendra is the first oral PCSK9 inhibitor, a protein that slows cholesterol clearance, previously available only as costly injections like Repatha and Praluent. The pill costs $315 for a 30-day supply and is expected to be available in U.S. pharmacies within weeks.
Unlike statins, Lipfendra must be taken fasting in the morning with water, black coffee, or tea. Family doctors in the U.S. can prescribe it without requiring cardiology specialists. Clinical trials involving 2,912 participants over 24 weeks showed up to a 60% reduction in LDL cholesterol with side effects comparable to placebo. It was also effective for patients with heterozygous familial hypercholesterolemia, a genetic disorder causing high cholesterol from birth.
Dr. Pooja Benka of Merck noted that 70% of patients do not reach cholesterol targets with statins alone and highlighted the absence of muscle pain side effects common with statins. Dr. Erin Michos from Johns Hopkins University emphasized the advantage of PCSK9 inhibitors in lowering lipoprotein(a), a cholesterol-carrying protein linked to heart disease risk that statins do not affect. New guidelines recommend LDL levels below 70 for high-risk patients and below 55 for very high-risk individuals.
From a business perspective, the approval helps Merck diversify revenue ahead of the 2028 patent expiration of its cancer drug Keytruda. The FDA expedited the approval process through a special program for critical medications. Israeli researchers, including Prof. Yaakov Henkin from Soroka Medical Center and Ben-Gurion University, and Dr. Dov Gavish from Wolfson Medical Center, praised the drug’s efficacy and the convenience of oral administration, which may improve patient adherence and help prevent cardiovascular diseases. Heart disease causes approximately 6,500 deaths annually in Israel.
