Amgen's Repatha Shows Promising Results in Phase III Trial, Signaling Shift in Cardiovascular Disease Treatment

Amgen's cholesterol-lowering drug Repatha has demonstrated significant efficacy in reducing the risk of first heart attacks, according to recent Phase III trial results. This development, along with other advancements in Amgen's pipeline, positions the company to potentially become a leader in cardiometabolic risk management by the end of the decade.

VESALIUS-CV Trial Results

The VESALIUS-CV trial, which involved over 12,000 high-risk patients with atherosclerotic cardiovascular disease (ASCVD) or high-risk diabetes but no history of heart attack or stroke, has yielded impressive results. Patients received either Amgen's PCSK9 inhibitor Repatha or a placebo in addition to lipid-lowering therapy over approximately four and a half years.

Key findings from the trial include:

• A 25% reduction in major adverse cardiovascular events (MACE), including death, heart attack, or ischemic stroke
• A 36% reduction in first heart attacks compared to placebo
• Lowering of LDL-C (low-density lipoprotein cholesterol) to an average of 45 mg/dL
• No new safety signals were observed

Paul Burton, Amgen's Chief Medical Officer, described the results as "remarkable" and "one of the best datasets" he has seen in his 25-year career in cardiometabolic drug development.

Implications for Cardiovascular Disease Treatment

The VESALIUS-CV trial results could potentially change clinical practice in cardiology. BMO Capital Markets analysts suggest that these findings may lead to earlier use of PCSK9 treatment in patients without optimal LDL-C control.

Repatha, first approved by the FDA in 2015 as an adjunct treatment for high LDL-C, is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke. This breakthrough could expand the drug's use in preventative care, potentially benefiting a broader patient population.

Amgen's Cardiovascular Pipeline and Future Prospects

Amgen is not resting on its laurels with Repatha's success. The company is actively developing other promising candidates in the cardiovascular space:

1. Olpasiran: An siRNA that lowers lipoprotein(a), currently in Phase III trials for patients with atherosclerotic cardiovascular disease. The primary completion date is set for December 2026.

2. MariTide: A much-discussed asset that shows promise in reducing weight and BMI while offering multiple cardiovascular benefits. A Phase III cardiovascular outcomes trial in patients with atherosclerotic cardiovascular disease and overweight or obesity began this summer, with a primary completion date of June 2028.

Paul Burton expressed optimism about Amgen's future in cardiometabolic risk management, stating, "When you bring that suite of medicines together, clearly we need two more pieces of the puzzle to fall into place. We need the outcome study of olpasiran to be positive, and we need the ongoing studies of MariTide to also be positive, but we have very strong Phase II data for both of them."

Burton anticipates that with the potential approval of both MariTide and olpasiran in the second half of this decade, Amgen could become the "undisputed leader in the management of cardiometabolic risk for patients."