Amgen's Repatha Reduces Cardiovascular Event Risk by 31%
Amgen announced that Repatha, when added to statins or other low-density lipoprotein cholesterol-lowering treatments, reduced the risk of first major adverse cardiovascular events in high-risk primary prevention patients without known significant atherosclerosis and with diabetes. The findings were presented in a late-breaking session at the American College of Cardiology 75th Annual Scientific Session and simultaneously published in the Journal of the American Medical Association. The results are from a new subgroup analysis of 3,655 patients at increased risk of CV events without known significant atherosclerosis followed for a median of 4.8 years from the Phase 3 VESALIUS-CV clinical trial. Results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction or ischemic stroke by 31% compared with placebo. Repatha also reduced the risk of a dual composite primary endpoint that included ischemia-driven revascularization by 31%. The median achieved LDL-C was 44 mg/dL at 96 weeks in the Repatha added to optimized lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimized lipid-lowering therapy arm.
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- Clinical Trial Results: In the VESALIUS-CV trial, Repatha significantly reduced the risk of cardiovascular events in high-risk patients, with a 31% reduction in the composite primary endpoint (CHD death, myocardial infarction, or ischemic stroke), highlighting its importance in high-risk primary prevention.
- LDL-C Reduction Effectiveness: The Repatha group achieved a median LDL-C level of 44 mg/dL at 96 weeks, compared to 105 mg/dL in the placebo group, demonstrating its significant advantage in cholesterol reduction and potentially offering new treatment options for early cardiovascular intervention.
- Secondary Endpoint Performance: Repatha showed a 31% reduction in heart attack risk, a 34% reduction in ischemia-driven revascularization, and a 33% reduction in ischemic stroke among secondary endpoints, further proving its potential in cardiovascular health management.
- Strategic Implications: Amgen emphasizes that earlier and more intensive LDL-C lowering is critical for preventing cardiovascular events, and the findings from Repatha support the new ACC/AHA guidelines, driving a strategic shift in cardiovascular disease management.
- Biosimilar Approval: Teva Pharmaceutical's Ponlimsi (denosumab-adet) has received FDA approval as a biosimilar to Amgen's Prolia (denosumab), which is projected to generate approximately $4.4 billion in revenue in 2025, indicating Teva's potential in the osteoporosis treatment market.
- Increased Market Competition: As Prolia is Amgen's best-selling drug, Teva's approval may exert competitive pressure, potentially leading to a decline in Prolia's market share, which could adversely affect Amgen's revenue and market position.
- Regulatory Review Progress: Teva also announced that the FDA and the European Medicines Agency have agreed to review its biosimilar applications for Genentech and Novartis' Xolair (omalizumab), which reported sales of approximately $3.8 billion and $1.7 billion in 2025, respectively, showcasing Teva's expansion potential in respiratory disease treatments.
- Optimistic Industry Outlook: With the FDA relaxing testing rules for biosimilars, Teva's applications are likely to receive more support, potentially driving growth for other generic drug suppliers in the industry, thereby enhancing market competition and drug accessibility.
- Annual Reconstitution Update: The Schwab U.S. Dividend Equity ETF has optimized its portfolio through the deletion of 22 stocks and the addition of 25 new stocks in its latest annual reconstitution, ensuring it holds the top 100 high-yield dividend stocks and enhancing overall portfolio quality.
- Increased Healthcare Allocation: Following the reconstitution, the allocation to the healthcare sector has risen from 15.4% to 18.9%, with UnitedHealth and Abbott Laboratories joining the top ten holdings at 4% and 3.95% respectively, thereby strengthening the fund's investment in the healthcare sector.
- Dividend Growth Potential: While the overall dividend yield of the ETF remains at 3.4% post-reconstitution, the new holdings boast a higher average five-year dividend growth rate of 9.4%, which is expected to generate greater long-term income for investors, enhancing the fund's appeal.
- Strong Dividend Track Record: Both UnitedHealth and Abbott Laboratories have impressive dividend growth records, with the former increasing dividends by 52% over the past five years and the latter by 40%, providing investors with a stable income source and further solidifying the ETF's investment value.
- Healthcare Stock Increase: The Schwab U.S. Dividend ETF's recent annual reconstitution added two healthcare stocks, raising the sector's allocation from 15.4% to 18.9%, making it the second-largest sector, indicating a strategic focus on the growth potential of healthcare.
- High-Yield Stock Selection: During this reconstitution, UnitedHealth and Abbott Laboratories were added to the top ten holdings with allocations of 4% and 3.95%, respectively, reflecting the fund's preference for high-yield healthcare stocks, which is expected to enhance long-term investor returns.
- Dividend Growth Potential: The new holdings have an average dividend growth rate of 9.4%, surpassing the pre-reconstitution rate of 8.6%, and while the overall yield remains at 3.4%, the faster growth rate could lead to higher total returns for investors in the future.
- Strong Dividend Records: Both UnitedHealth and Abbott have robust dividend growth histories, with the former increasing its dividend by 52% over the past five years and the latter by 40%, showcasing the attractiveness and stability of the healthcare sector in dividend investing.
- Cardiovascular Event Risk Reduction: In the VESALIUS-CV clinical trial, Repatha reduced the risk of first major adverse cardiovascular events by 31% in high-risk primary prevention patients, highlighting its critical role in cardiovascular disease prevention.
- Significant LDL-C Reduction: The Repatha treatment group achieved a median LDL-C level of 44 mg/dL at 96 weeks, compared to 105 mg/dL in the placebo group, indicating its substantial efficacy in cholesterol lowering, potentially offering better cardiovascular protection for patients.
- Strategic Importance of Early Intervention: The findings underscore the importance of early and more intensive LDL-C lowering strategies in high-risk patients without known atherosclerosis, which may effectively reduce risk before cardiovascular events occur.
- Broad Applicability: Since its approval in 2015, Repatha has been used in over 8 million patients globally, demonstrating its wide applicability and potential market opportunities in cardiovascular disease management.
- Cardiovascular Event Risk Reduction: In a study involving 3,655 high-risk patients, Repatha significantly reduced the risk of first major adverse cardiovascular events by 31%, underscoring its critical role in high-risk primary prevention.
- Significant LDL-C Level Reduction: After 96 weeks of treatment, the median LDL-C level in the Repatha group was 44 mg/dL compared to 105 mg/dL in the placebo group, demonstrating Repatha's superior efficacy in cholesterol reduction, potentially offering better cardiovascular protection for patients.
- Strategic Importance of Early Intervention: The findings emphasize the importance of early and intensive LDL-C lowering strategies in high-risk patients without known atherosclerosis, which may effectively reduce the risk before cardiovascular disease onset.
- Broad Clinical Application: Since its approval in 2015, Repatha has been used in over 8 million patients globally, and the FDA expanded its indications in 2025, further solidifying its position in cardiovascular disease management.











