Overview
- Amgen presented AHA data from more than 12,000 U.S. patients with diabetes or atherosclerosis and no prior heart attack or stroke, showing a 25% reduction in serious cardiovascular events with Repatha added to standard therapy.
- Study leaders said this is the first PCSK9 inhibitor to demonstrate efficacy for preventing an initial cardiovascular event.
- The trial population had a median age of 66 with 43% women and 93% white participants, highlighting questions about broader generalizability.
- Repatha is an injectable antibody that blocks PCSK9 to lower LDL cholesterol and is often considered when statins are insufficient or not tolerated, though injections and cost have limited uptake.
- Merck is advancing an oral PCSK9 candidate, Enlicitide, with early reports of up to 60% LDL reduction and about 20% fewer events in initial studies, and a planned FDA filing in early 2026 targeting a 2027 launch.