FDA approves oral drug meant to help reduce LDL cholesterol

The U.S. Food and Drug Administration recently approved Lipfendra, an oral medication designed to reduce low-density lipoprotein cholesterol in adults. This new drug, also known as enlicitide, marks a significant change for patients managing high cholesterol. Previously, the only available PCSK9 inhibitors required injections. Now, adults can manage their condition with a daily tablet.

Hypercholesterolemia often leads to plaque buildup on artery walls. This process narrows blood vessels and increases the risk of heart attacks and strokes. Many individuals live with the condition without experiencing symptoms, making routine blood tests vital for detection.

Clinical trials involving over 3,000 adults with hypercholesterolemia showed that Lipfendra effectively reduces LDL levels when used alongside standard care like statins. In one study of patients with established atherosclerotic cardiovascular disease, the drug led to a 56% average reduction in LDL cholesterol compared to a placebo. Another trial focused on patients with heterozygous familial hypercholesterolemia, where participants saw a 59% reduction.

Merck Sharp & Dohme LLC received approval for this drug under the Priority Review program. The treatment is intended for use in combination with proper diet and physical activity. By offering an oral option, medical providers can improve access for patients who struggle with injectable therapies. This advancement highlights the ongoing work to address chronic cardiovascular health issues and decrease long-term risks for American adults.