Amgen's Repatha Seizes Cardiovascular Opportunity with Expanded Label

Amgen is expanding its presence in cardiovascular medicine as Repatha, its cholesterol-lowering drug, gains traction following a significant regulatory win. The US FDA granted Repatha a label expansion, allowing it to be used for primary prevention in adults at risk of cardiovascular events.

The change follows positive results from the phase 3 Vesalius-CV study, which showed that Repatha significantly reduced the risk of major adverse cardiovascular events compared to standard treatment alone. The trial enrolled patients who had not previously suffered a heart attack or stroke, broadening the eligible population.

Repatha's commercial performance has reflected this growing opportunity, with Amgen reporting a 36% sales increase to $2.22 billion in full-year 2024. This momentum continued into the following year, with second-quarter sales rising 31% to $696 million against the same period twelve months prior.

However, Amgen faces long-term challenges that could put pressure on Repatha's dominance before the end of the decade. The drug is expected to come under price controls through the Inflation Reduction Act in 2029 and may face biosimilar competition starting in the next decade. Outside the US, Repatha retains market exclusivity until May 2032 if certain patents remain intact.