Every year the American College of Cardiology annual meeting brings together leaders from across the cardiovascular community to learn about the latest academic research in cardiovascular health. But despite great advances in recent years, cardiovascular disease remains a leading public health challenge globally.1 Amgen has maintained an ongoing commitment to helping people with cardiovascular disease. But no company can do it alone. It takes coordinated efforts in patient education, healthcare access and public health, along with continued biomedical innovation, to address unmet needs in preventing subsequent cardiovascular events and treating cardiovascular disease.
Here are 5 things that Amgen is doing to help people with cardiovascular disease:
1. Decoding human biology to unlock new treatments
Sometimes genetic insights lead to the development of a new target or new therapy in a remarkably short time frame, as was the case with Amgen’s development of Repatha® (evolocumab), the first PCSK9i inhibitor approved to reduce cardiovascular events like heart attack and stroke in patients with cardiovascular disease, and monoclonal antibodies that have now been used to treat more than 1 million patients.2,3 Through its work with deCODE, about 65% of Amgen’s non-oncology portfolio has been genetically validated to various degrees.4
2. Addressing cardiovascular disease in places with the highest unmet needs1
To increase understanding of this globally important issue, in 2019, Amgen and the CDC Foundation partnered on a five-year, global cardiovascular health initiative to expand the evidence base for cardiovascular disease risk factors, with a focus on low- and middle-income countries. Through this collaboration, Amgen supports the collection and analysis of data to improve understanding of the causes of cardiovascular disease and interventions that may improve patient outcomes.
3. Designing research for the real world
While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered by clinical practices.5 Patients with cardiovascular disease often have comorbidities and socio-economic factors that impact treatment outcomes.6,1 That’s why Amgen is investing in studies to evaluate treatment effectiveness in real-world settings.7
4. Closing the gap in disease management
LDL-C (or “bad” cholesterol) is one of the most important modifiable risk factors in reducing a person’s risk of a second cardiovascular event, and studies have shown that many people who are at very high-risk are not being treated to the guidelines established by the American College of Cardiology and the American Heart Association, and more intensive efforts are needed.8,9 To help close this gap in care, Amgen is collaborating with the American College of Cardiology and others on a national study (TRANSFORM: ACS) to help ensure that people with acute coronary syndrome (ACS) quickly receive cholesterol testing in the hospital, as well as guideline-recommended therapies to reduce LDL cholesterol in the hospital and upon discharge.10
5. Collaborating to remove barriers to treatment
Some challenges can’t be solved alone. Or even through partnerships. Some challenges are so big that they require a collective effort, like the systemic barriers that prevent many patients with cardiovascular disease from accessing PCSK9i monoclonal antibody treatments, which can lower LDL-C levels by more than 50%.11 That’s why Amgen is bringing together community stakeholders to find solutions, including collaborations with the Partnership to Advance Cardiovascular Health (PACH) and the Association of Black Cardiologists. By working with PACH, Amgen is helping payers understand the impact of restrictive health plan formulary decisions on heart health outcomes, while Amgen’s collaboration with the Association of Black Cardiologists seeks to improve patient and provider understanding of evidence-based lipid management and other therapies across the cardiovascular disease spectrum and advocates for solutions to address health disparities experienced by African American patients.
Solving systemic challenges will take a concerted effort by many stakeholders, and change won’t happen overnight. Until then, Amgen is committed to helping patients afford treatment. Amgen was the first manufacturer to the lower the price of its PCSK9i in 2019 and it helps Repatha patients stay on their treatment as prescribed by their doctor through various patient support resources including a copay card program for eligible commercially insured patients.12
INDICATIONS
Repatha® is indicated:
- In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
- As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C
IMPORTANT SAFETY INFORMATION
Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.
Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.
Please see full Prescribing Information.
References:
- World Health Organization. (2021, June 11). Cardiovascular diseases (cvds). World Health Organization. Retrieved April 1, 2022, from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
- Amgen. (2017, December 1). FDA Approves Amgen's Repatha® (evolocumab) To Prevent Heart Attack And Stroke [Press Release]. https://www.amgen.com/newsroom/press-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke
- Amgen Data on File. 2021.
- Amgen. (2022, February 202). Amgen Business Review Meeting [Investor Presentation]. https://investors.amgen.com/static-files/6d823d7d-2fd1-405a-8c0e-22aa91bee682
- Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology, 125(13), 1716. https://doi.org/10.1111/1471-0528.15199
- Cruz-Ávila, H. A., Vallejo, M., Martínez-García, M., & Hernández-Lemus, E. (2020, August 28). Comorbidity networks in cardiovascular diseases. Frontiers. Retrieved April 1, 2022, from https://www.frontiersin.org/articles/10.3389/fphys.2020.01009/full
- Amgen. (2019, November 15). Amgen And The Duke Clinical Research Institute Announce Initiation Of First Large-Scale Registry To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors [Press release]. https://www.amgen.com/newsroom/press-releases/2019/11/amgen-and-the-duke-clinical-research-institute-announce-initiation-of-first-large-scale-registry-to-evaluate-real-world-lipid-management-and-the-effectiveness-of-pcsk9-inhibitors
- Understand your risks to prevent a heart attack. www.heart.org. (2022, February 10). Retrieved April 1, 2022, from https://www.heart.org/en/health-topics/heart-attack/understand-your-risks-to-prevent-a-heart-attack
- Graham G. (2015). Disparities in cardiovascular disease risk in the United States. Current cardiology reviews, 11(3), 238–245. https://doi.org/10.2174/1573403x11666141122220003
- American College of Cardiology. (2020, December 15). American College of Cardiology to Collaborate with Amgen, Veradigm to Optimize ACS Care [Press Release]. https://www.acc.org/about-acc/press-releases/2020/12/15/15/06/american-college-of-cardiology-to-collaborate-with-amgen-veradigm-to-optimize-acs-care
- Chaudhary, R., Garg, J., Shah, N., & Sumner, A. (2017). PCSK9 inhibitors: A new era of lipid lowering therapy. World journal of cardiology, 9(2), 76–91. https://doi.org/10.4330/wjc.v9.i2.76
- Amgen. (2019, October 24). Amgen To Make Repatha® (evolocumab) Available Exclusively At Its Lower List Price Option In 2020 [Press release]. https://www.amgen.com/newsroom/press-releases/2019/10/amgen-to-make-repatha-evolocumab-available-exclusively-at-its-lower-list-price-option-in-2020.
