Amgen is pushing deeper into cardiovascular medicine as its cholesterol drug Repatha continues to gain ground following a significant regulatory milestone.
The US Food and Drug Administration granted Repatha a label expansion that opened the door to a primary prevention setting for adults at risk of cardiovascular events.
Previously, the drug’s approval was limited to secondary prevention, requiring patients to have already established cardiovascular disease before qualifying for treatment.
The expansion follows positive results from the phase 3 Vesalius-CV study, in which Repatha significantly reduced the risk of major adverse cardiovascular events compared with standard treatment alone.
Crucially, the trial enrolled patients who had not previously suffered a heart attack or stroke, broadening the potential eligible population considerably.
Analysts at Leerink Partners described the overall market for primary prevention as “vast,” noting that there are “tens of millions of patients globally still not reaching LDL-C goals despite available therapies.”
Repatha’s commercial performance has reflected that growing opportunity, with Amgen reporting a 36% sales increase to $2.22 billion across the full year of 2024.
That trajectory has continued strongly into the following year, with second-quarter sales rising 31% to $696 million against the same period twelve months prior.
Despite the strong momentum, Amgen faces a set of 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, a significant commercial headwind for one of the company’s most important revenue generators.
Biosimilar competition is also expected to begin eroding Repatha’s US market position at the start of the next decade, intensifying pressure on Amgen to diversify its cardiovascular portfolio.
Outside the United States, Repatha could retain market exclusivity until May 2032 if certain patents remain intact, offering some buffer against the looming competitive threat.
Amgen is also advancing other assets in the cardiovascular and metabolic space, including MariTide and an investigational siRNA drug called olpasiran, to support its broader ambitions.
Amgen Chief Medical Officer Paul Burton articulated the company’s longer-term goal, stating that with these assets the ambition “is to be the global leader in the management of cardiometabolic risk by 2030.”
Burton added: “We think we have really important medicines that can address that unmet medical need, and it’s why we feel so confident that we can realize that ambition by 2030.”