What is Merck's Lipfendra PCSK9 pill and why did the FDA approve it?

Merck’s Lipfendra is the first oral PCSK9 cholesterol-lowering pill approved by the FDA. The drug gained clearance through a priority pathway linked to a controversial voucher program launched under former FDA commissioner Marty Makary. Its approval marks Merck’s entry into a high-value cholesterol market dominated by injectables.