FDA approves Lipfendra — the first oral PCSK9 inhibitor
Merck's once-daily pill lowered LDL by ~56–59% vs placebo in two late-stage trials, holding up in familial hypercholesterolemia. The breakthrough is the route: PCSK9 lowering without an injection — an access and adherence shift for statin-inadequate patients. Open question: cardiovascular-outcomes data vs the LDL surrogate.