The U.S. Food and Drug Administration approved Merck’s Lipfendra (enlicitide) for the treatment of hypercholesterolemia. This once-daily pill represents the first oral PCSK9 inhibitor approved for patients. It provides an alternative to existing injectable cholesterol treatments.
Phase 3 trials showed the drug reduced LDL cholesterol by nearly 60% compared to a placebo. Lipfendra is designed for use in combination with diet and exercise.
The availability of an oral medication is expected to increase patient access to this drug class. Analysts project the treatment could reach $5 billion in peak annual sales.