Amgen's Repatha Shows Promise in Cardiovascular Disease Prevention

Amgen's cholesterol-lowering drug Repatha (evolocumab) has demonstrated significant potential in preventing cardiovascular events in high-risk patients without prior heart disease, according to recent clinical trial results. This development could expand the drug's reach and solidify its position in the competitive cardiovascular medication market.

Phase III VESALIUS-CV Trial Results

The Phase III VESALIUS-CV study, involving over 12,300 patients, has yielded positive outcomes for Repatha in primary prevention of cardiovascular disease. Amgen reported that the trial met its primary endpoints, showing a statistically and clinically significant reduction in the risk of major adverse cardiovascular events (MACE) compared to standard care alone.

Key findings from the study include:

• Significant lowering of the risk of heart complications in patients without prior cardiovascular disease
• Positive results in a composite endpoint including heart attack, ischemic stroke, and death from coronary heart disease
• No new safety concerns reported

The trial followed patients for a median of approximately 4.5 years, with 85% of participants receiving high-intensity or moderate therapy to manage their LDL cholesterol levels alongside Repatha.

Implications for Repatha's Market Position

Repatha, a PCSK9 inhibitor first approved in 2015, has seen its indications expand over the years. The recent FDA label expansion in August 2024 removed the requirement for patients to have a prior diagnosis of cardiovascular disease, paving the way for broader use in primary prevention.

The VESALIUS-CV trial results further support this expansion, potentially allowing Repatha to reach a larger patient population. Analysts from Leerink Partners note that while some physicians already prescribe Repatha off-label for primary prevention, the formal label expansion and new data should drive broader adoption.

Amgen reported strong sales growth for Repatha, with a 36% increase to $2.22 billion in 2024 and a 31% year-over-year growth to $696 million in Q2 2025. However, the drug faces future challenges, including potential price controls under the Inflation Reduction Act in 2029 and the emergence of biosimilars in the early 2030s.

Market Outlook and Competition

The primary prevention market for cardiovascular disease is vast, with tens of millions of patients globally not reaching LDL-C goals despite available therapies. Repatha's latest results position it favorably in this space, though the impact on sales remains to be seen.

Amgen plans to present the full findings from the VESALIUS-CV study at the American Heart Association Scientific Sessions on November 8, 2025. The pharmaceutical industry and medical community eagerly await these detailed results, which could further shape the landscape of cardiovascular disease prevention and treatment.