New Novartis data show early addition of twice-yearly* Leqvio® (inclisiran) following maximally tolerated statin therapy significantly reduces LDL-C in ASCVD patients in real-world setting
- V- INITIATE trial demonstrates that early initiation with Leqvio, prior to guideline-recommended ezetimibe, for ASCVD patients unable to achieve LDL-C goal on statin therapy alone led to significant LDL-C reduction vs. clinician-determined usual care (60% vs. 7% respectively)1
- A significantly greater proportion of the ASCVD patients receiving Leqvio achieved guideline-recommended LDL-C goal vs. the usual care arm while maintaining adherence to statin treatment1
- Results from usual care arm reinforce the urgent need for more aggressive LDL-C lowering in ASCVD patients, 92% of whom did not reach their LDL-C goal with statins alone1
- The Leqvio safety profile was consistent with the Phase III clinical studies and long-term open-label extension trials for up to 6 years of treatment1-4
"V-INITIATE evaluated a solution to the important challenge seen in clinical practice of too many patients with ASCVD not achieving guideline-recommended LDL-C goal on statins alone and effective non-statin therapies being markedly underutilized," said
In the V-INITIATE study, patients receiving Leqvio experienced significant reductions in LDL-C compared to those receiving usual care (60% vs. 7%, respectively; p<0.001), which consisted mostly of statin therapy alone (73%)1. Four in five patients receiving Leqvio achieved the guideline-recommended LDL-C goal of <70 mg/dL compared to just one in five patients receiving usual care (81.8% vs. 22.2%, respectively; p<0.001)1. Notably, patients receiving health care provider (HCP)-administered Leqvio maintained adherence to existing lipid-lowering therapy, and the discontinuation rate of background statin therapy did not differ between the Leqvio and usual care arms (5.8% vs. 16.7%, respectively)1.
The safety results from V-INITIATE were consistent with findings from the pivotal Phase III clinical trial program and long-term open-label extension trials, ORION-3 and ORION-8, which demonstrated sustained safety for up to six years of treatment1-4.
"The data from V-INITIATE illustrate that earlier initiation of innovative non-statin therapies, like Leqvio, presents a real opportunity to do better for ASCVD patients and improve the way we approach LDL-C lowering," said
V-INITIATE is a 12-month Phase IIIb open-label study evaluating the effectiveness of adding Leqvio earlier, following a patient's failure to reach LDL-C goal on maximally tolerated statin therapy, compared to usual care, in a setting that reflects
*After an initial dose and another at three months.
Indication
LEQVIO (inclisiran) is an injectable prescription medicine used along with diet and other cholesterol-lowering medicines in adults with high blood cholesterol levels called primary hyperlipidemia (including a type of high cholesterol called heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein (LDL-C) or "bad" cholesterol.
Important Safety Information:
The most common side effects of Leqvio were: injection site reaction (including pain, redness, and rash), arthralgia (joint pain), bronchitis (chest cold).
These are not all the possible side effects of Leqvio. Ask your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here for Leqvio full Prescribing Information.
About Leqvio
Leqvio is a subcutaneous injection given by a health care provider (HCP) with an initial dose, another at three months, and then every six months2,5. As a twice-yearly, HCP-administered treatment, Leqvio may help to circumvent the challenges of treatment adherence, a common issue in cholesterol management. Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 90 countries, including the
About V-INITIATE
V-INITIATE is a 12-month, randomized, multicenter, open-label Phase IIIb study in 450 atherosclerotic cardiovascular disease (ASCVD) patients in the
About VictORION
The V-INITIATE trial is part of VictORION, an innovative and robust clinical program for Leqvio, comprising more than 30 trials and enrolling over 60,000 patients in more than 50 countries worldwide7. The program is designed to expand on the foundational evidence of LDL-C reduction with Leqvio in diverse patient populations to include randomized clinical trials, implementation research, real-world evidence, and trials that aim to establish its potential benefits on cardiovascular outcomes in primary and secondary prevention. A growing number of studies are planned to generate a vast array of data with major trials such as ORION-4 (secondary prevention), V(VictORION)-2-PREVENT (secondary prevention), V-1-PREVENT (high-risk primary prevention), V-INCEPTION and V-MONO.
About Atherosclerotic Cardiovascular Disease (ASCVD)
ASCVD refers to a variety of diseases caused by the development and growth of plaques in the inner lining of the arteries8. The atherosclerotic plaque is mainly composed of low-density lipoprotein cholesterol (LDL-C) which accumulates over time8. Cumulative exposure to LDL-C is proportionally related to arterial plaque growth and progression leads to subsequent risk of cardiovascular events such as a heart attack or stroke8,9. Accounting for 85% of all cardiovascular disease deaths, ASCVD is the primary cause of mortality in the
About
Cardiovascular disease (CVD) affects hundreds of millions of people and claims more lives globally than cancer, chronic lung disease and diabetes combined14. It is time to change that. Around 80% of premature cardiovascular deaths can be prevented by addressing factors that cause or worsen CVD15. We have a responsibility to make that a reality for more people.
Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in
About Novartis
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References
- Koren MJ, Rodriguez F, East CA, et al. Comparison of an "inclisiran first" strategy with usual care in patients with atherosclerotic cardiovascular disease: results from the VICTORION-INITIATE randomized trial. Data presented at:
American College of Cardiology Congress ;April 6, 2024 ;Atlanta, GA. - Leqvio. Prescribing information.
Novartis Pharmaceuticals Corp. - Wright RS, Raal FJ, Koenig W, et al. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. Data presented at:
European Society of Cardiology Congress ;August 28, 2023 ;Amsterdam, the Netherlands . - Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109-119.
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European Medicines Agency . Leqvio (inclisiran): An overview of Leqvio and why it is authorized in the EU. Last updatedJune 2021 . AccessedMarch 12, 2024 . https://www.ema.europa.eu/en/documents/overview/leqvio-epar-medicine-overview_en.pdf -
National Medical Products Administration . Drug approval document delivery information. PublishedAugust 24, 2023 . AccessedMarch 12, 2024 . https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20230824155809182.html - Data on file. NCT04929249. Novartis Pharmaceuticals Corp; 2024.
- Goldstein JL, Brown MS. A century of cholesterol and coronaries: from plaques to genes to statins. Cell. 2015;161(1):161-172.
- Ference BA, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids on cardiovascular health: JACC Health Promotion Series. J Am Coll Cardiol. 2018;72(10):1141-1156.
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World Health Organization . Cardiovascular diseases (CVDs). Published June 11, 2021. Accessed March 12, 2024. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds) - Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2012 update: a report from the
American Heart Association . Circulation. 2012;125(1):e2-e220. - Kim H, Kim S,
Han S , et al. Prevalence and incidence of atherosclerotic cardiovascular disease and its risk factors inKorea : a nationwide population-based study.BMC Public Health . 2019;19(1):1112. - Grundy SM, Stone NJ, Bailey AL, et al. 2018
AHA/ACC/AACVPR/AAPA/ABC /ACPM /ADA /AGS/APhA/ASPC /NLA/PCNA guideline on the management of blood cholesterol: a report of theAmerican College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines . Circulation. 2019;139:e1082–e1143. -
American Heart Association . More than half of U.S. adults don't know heart disease is leading cause of death, despite 100-year reign. PublishedJanuary 24, 2024 . AccessedMarch 12, 2024 . https://newsroom.heart.org/news/more-than-half-of-u-s-adults-dont-know-heart-disease-is-leading-cause-of-death-despite-100-year-reign -
World Heart Federation . World Heart Report. PublishedMay 20, 2023 . AccessedMarch 12, 2024 . https://world-heart-federation.org/wp-content/uploads/World-Heart-Report-2023.pdf
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