Amgen Receives FDA Approval for Olpasiran in Atherosclerotic Cardiovascular Disease

Amgen today announced that the FDA has approved olpasiran for the reduction of major adverse cardiovascular events in adults with established atherosclerotic cardiovascular disease and elevated lipoprotein(a) levels. In the Phase 3 OCEAN(a) trial, olpasiran reduced major adverse cardiovascular events by a statistically significant margin compared to placebo, along with a 95% reduction in Lp(a) levels. Olpasiran is a subcutaneous, twice-yearly siRNA that inhibits hepatic Lp(a) production. This approval establishes Lp(a) lowering as a validated cardiovascular risk reduction strategy.