Merck Secures Oral PCSK9 Approval Amid Diversified Growth Plans

Merck has secured FDA approval for LIPFENDRA, its oral PCSK9 inhibitor for cholesterol management. The drug targets adults with hypercholesterolemia who require additional LDL cholesterol lowering beyond existing therapies.

This approval marks a significant shift in the treatment class, which has previously been dominated by injectable PCSK9 therapies.

Merck's acquisition and licensing strategy has nearly tripled its late-stage pipeline since 2021, with over $50 billion in potential commercial opportunity expected by the mid-2030s.