FDA approves Merck's first oral PCSK9 inhibitor pill for lowering cholesterol, expanding treatment options.

The US FDA has approved Merck's Lipfendra, the first oral PCSK9 inhibitor pill designed to lower LDL cholesterol in patients with hypercholesterolemia, including hereditary cases. This pill offers a new alternative to injectable drugs, potentially increasing treatment adherence among patients at risk of heart disease. Lipfendra will be priced at $10.50 per day and is expected to be available within weeks. Clinical trials showed it can reduce LDL cholesterol by nearly 60%, and ongoing studies are assessing its impact on cardiovascular outcomes. Analysts predict peak sales could reach $5 billion by 2034, highlighting its significant market potential.