Merck Eyes Blockbuster Potential with Lipfendra, the First Oral PCSK9 Drug

Merck is betting Lipfendra—the first oral PCSK9 inhibitor—will unlock a sluggish market after gaining July FDA approval via the Commissioner’s National Priority Voucher (CNPV) program, with initial demand rising but payer access likely slow; priced at $315 per month and supported by a direct-to-patient discount plan, Merck sees long-term blockbuster potential and is exploring combos with rosuvastatin and MK-7262, plus an outcomes study due in 2029.