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NewsTelemundo 51 Miami – MainJuly 16, 2026Miami-Dade

FDA Approves New Oral Medication for High Cholesterol

The FDA has approved Lipfendra, a new oral medication by Merck designed to lower LDL ('bad') cholesterol in adults. It is the first oral PCSK9 inhibitor approved for use alongside diet and exercise, offering an alternative to existing injectable treatments.

FDAHealthCholesterolPharmaceuticalsMedicine
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Why It Matters

Adults with high cholesterol or familial hypercholesterolemia now have access to a new daily pill option priced at $10.50 per day to manage their cardiovascular health risks.

Key Facts

  • The FDA approved Lipfendra as the first oral PCSK9 inhibitor for treating high LDL cholesterol.
  • Lipfendra is intended for use in combination with diet and exercise.
  • The medication is indicated for adults with high cholesterol and those with heterozygous familial hypercholesterolemia (HeFH).
  • The list price for Lipfendra is $10.50 per day, based on a 30-day supply.
  • The drug functions by blocking the PCSK9 protein, which helps the body remove LDL cholesterol from the blood.
  • Approval was based on two clinical trials involving 3,207 adults.
  • Clinical trials showed a reduction in LDL cholesterol over a 24-week period compared to a placebo group.
  • Trial data indicated that discontinuation rates due to adverse reactions were similar between the Lipfendra and placebo groups.

Who's Mentioned

organizationRegeneron“Manufacturer of the injectable cholesterol drug Praluent.”otherLipfendra“The newly approved oral medication for cholesterol.”organizationSanofi“Manufacturer of the injectable cholesterol drug Praluent.”organizationFDA“The U.S. Food and Drug Administration, which approved the new medication.”organizationAmgen“Manufacturer of the injectable cholesterol drug Repatha.”other3,207“Number of adults who participated in the clinical trials.”organizationMerck“The pharmaceutical company that manufactures Lipfendra.”