Banner background image Banner background image

POWERFUL AND CONSISTENT
LDL-C REDUCTION1

In ORION-10 (N=1561) on top
of a maximally tolerated statin

52% LDL-C reduction

difference from placebo at month 17 (95% CI: -56%, -49%; P<0.0001)1 (LEQVIO n=781 or placebo n=780)1

LDL-C reduction on top of a maximally tolerated statin 1

PATIENTS WITH ASCVD
On top of a maximally tolerated statin, LEQVIO demonstrated a 52% reduction from placebo at month 17

For the best experience, please view in landscape orientation.

84% of patients achieved guideline-recommended LDL-C target

compared with 18% of patients on placebo at month 173,10

Study Design: ORION-10 (N=1561) & ORION-11 (N=1617) were multicenter, double-blind, randomized, placebo-controlled, 18-month, Phase III trials in patients with established ASCVD (ORION-10 and ORION-11) or increased risk for CVD§ (ORION-11). Patients were taking a maximally tolerated statin with or without other lipid-modifying therapy and required additional LDL-C reduction. The primary efficacy measure was the percent change in LDL-C from baseline to day 510.1,2

CONSISTENT EFFICACY BEYOND 6 YEARS1,8,9*

In ORION-8 (N=3274), an open-label extension study

~80% OF PATIENTS

achieved guideline-recommended LDL-C target3,8‡

(78%; 95% CI: 77, 80)8,9

~50% LDL-C REDUCTION

n=2731 (49% at end of study||; 95% CI: 48%, 50%)8,9

Study Design: ORION-8, an open-label extension trial that included 3274 patients from ORION-9, ORION-10, ORION-11, and ORION-3, was designed to assess the long-term safety, efficacy, and tolerability of LEQVIO in patients with ASCVD or increased risk for CVD§ and elevated LDL-C, despite ongoing treatment with lipid-lowering therapy.8,9

Limitations: Study was not blinded nor controlled and includes inherent self-selection bias for continuing onto the extension trial. The open-label design and absence of a control group may present difficulties in the interpretation of results, allowing comparisons only to baseline values.

*209 (6.4%) patients had exposure to LEQVIO for 6+ years, 213 (6.5%) patients had exposure to LEQVIO for 5+ years, 1553 (47.4%) patients had exposure for 4+ years, and 2095 (64%) patients had exposure for 3+ years.30

Greater LDL-C reduction was maintained during each 6-month dosing interval vs placebo as a complement to a maximally tolerated statin.1

LDL-C target was <70 mg/dL for patients with ASCVD and <100 mg/dL for patients at increased risk for CVD§ and aligns with AHA/ACC guidelines.3,8

§ Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.2

|| End of study was defined as day 1080 or ≥90 days after the last LEQVIO dose.8

For the best experience, please view in landscape orientation.

LEQVIO DEMONSTRATED CONSISTENT REDUCTION ACROSS PREDEFINED SUBGROUPS5,6

Percent change in LDL-C from baseline at month 17 in a pooled analysis of Phase III trials5,6

Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11
Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11
Percent change in LDL-C from baseline at month 17 in a pooled analysis of ORION-10 and ORION-11

a Patients with a history of statin intolerance.

b Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.2


desktop14days 14-days-mobile

Study Description: ORION-1 was a Phase II, multicenter, double-blinded, randomized, placebo-controlled clinical trial of 345 subjects with established ASCVD who were taking a maximally tolerated statin and required additional LDL-C reduction. Of those, 91 patients received the 284-mg dose of LEQVIO. The primary efficacy end point was the percent reduction in LDL-C from baseline to day 180 and was calculated for multiple time points at days 14, 30, 60, 90, 120, 150, 180, 210, and 240.1,7

THERE'S MORE TO
KNOW ABOUT LEQVIO

Discover what makes LEQVIO dosing different

DIVE INTO DOSING arrow

ASCVD, atherosclerotic cardiovascular
disease; CI, confidence interval;
LDL-C, low-density lipoprotein cholesterol.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY
INFORMATION

COLLAPSE

EXPAND

EXPAND

COLLAPSE

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, and bronchitis.

Please click here for LEQVIO full Prescribing Information.

References: 1. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp. 2. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 3. 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 the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.000000000000062 4. Data on file. LEQVIO Coverage and Affordability. Novartis Pharmaceuticals Corp; 2023. 5. Wright RS, Ray KK, Raal FJ, et al. Pooled patient-level analysis of inclisiran trials in patients with familial hypercholesterolemia or atherosclerosis. J Am Coll Cardiol. 2021;77(9):1182-1193. doi:10.1016/j.jacc.2020.12.058 6. Data on file. Integrated Summary of Efficacy. Novartis Pharmaceuticals Corp. 7. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 8. Wright RS, Raal FJ, Koenig W, et al. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. Oral presentation at: European Society of Cardiology; August 25-28, 2023; Amsterdam, Netherlands. 9. Wright RS, Raal FJ, Koenig W, et al. ORION-8: an open-label extension trial of ORION-3/9/10/11 to assess long-term efficacy and safety of twice-yearly inclisiran in patients with high cardiovascular risk and elevated LDL-C. Abstract presented at: European Society of Cardiology; August 25-28, 2023; Amsterdam, Netherlands. 10. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020(supplement):1-31. 11. Wright RS. A pooled safety analysis of inclisiran in 3576 patients with approximately 10,000 person-years of exposure from seven trials. Oral presentation at: American College of Cardiology Annual Conference; March 2023; New Orleans, LA. 12. Data on file. LEQVIO 3-Year Shelf Life. Novartis Pharmaceuticals Corp; 2022. 13. Data on file. LEQVIO Container Closure System. Novartis Pharmaceuticals Corp; 2022. 14. Repatha. Prescribing information. Amgen Inc. 15. Khvorova A. Oligonucleotide therapeutics—a new class of cholesterol-lowering drugs. N Engl J Med. 2017;376(1):4-7. doi:10.1056/NEJMp1614154 16. Fitzgerald K, White S, Borodovsky A, et al. A highly durable RNAi therapeutic inhibitor of PCSK9. N Engl J Med. 2017;376:41-51. doi:10.1056/NEJMoa1609243 17. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 18. Jacobson TA, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(3):415-424. 19. Jones PH, Nair R, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 20. Maningat P, Gordon BR, Breslow JL. How do we improve patient compliance and adherence to long-term statin therapy? Curr Atheroscler Rep. 2013;15(1):291. 21. Mann DM, Woodward M, Muntner P, Falzon L, Kronish I. Predictors of nonadherence to statins: a systematic review and meta-analysis. Ann Pharmacother. 2010;44(9):1410-1421. doi:10.1007/s11883-012-0291-7 22. Benner JS, Glynn RJ, Mogun H, et al. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002;288(4):455-461. 23. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421. 24. Cannon CP, deLemos JA, Rosenson RS. Use of lipid-lowering therapies over 2 years in GOULD, a registry of patients with atherosclerotic cardiovascular disease in the US. JAMA Cardiol. 2021;6(9):1060-1068. doi:10.1001/jamacardio.2021.1810 25. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 26. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. J Clin Lipidol. 2016;10(5):1109-1118. 27. Data on file. PCSK9 Discontinuation. Novartis Pharmaceuticals Corp; 2023. 28. Hines DM, Rane P, Patel J, Harrison DF, Wade RL. Treatment patterns and patient characteristics among early initiators of PCSK9 inhibitors. Vasc Health Risk Manag. 2018;14:409-418. doi:10.2147/VHRM.S180496 29. Data on file. Novartis Pharmaceuticals Corp; 2019. 30. Data on file. ORION-8 (CKJX839A12306B) Cumulative LEQVIO exposure. Novartis Pharmaceuticals Corp; 2023.

INDICATION

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).

IMPORTANT SAFETY INFORMATION

Adverse reactions in clinical trials (≥3% of patients treated with LEQVIO and more frequently than placebo) were injection site reaction, arthralgia, and bronchitis.

Please click here for LEQVIO full Prescribing Information.

References: 1. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp. 2. Ray KK, Wright RS, Kallend D, et al; ORION-10 and ORION-11 Investigators. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387 3. 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 the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25):e1082-e1143. doi:10.1161/CIR.000000000000062 4. Data on file. LEQVIO Coverage and Affordability. Novartis Pharmaceuticals Corp; 2023. 5. Wright RS, Ray KK, Raal FJ, et al. Pooled patient-level analysis of inclisiran trials in patients with familial hypercholesterolemia or atherosclerosis. J Am Coll Cardiol. 2021;77(9):1182-1193. doi:10.1016/j.jacc.2020.12.058 6. Data on file. Novartis Pharmaceuticals Corp; 2020. 7. Ray KK, Landmesser U, Leiter LA, et al. Inclisiran in patients at high cardiovascular risk with elevated LDL cholesterol. N Engl J Med. 2017;376(15):1430-1440. doi:10.1056/NEJMoa1615758 8. Wright RS, Raal FJ, Koenig W, et al. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. Oral presentation at: European Society of Cardiology; August 25-28, 2023; Amsterdam, Netherlands. 9. Wright RS, Raal FJ, Koenig W, et al. ORION-8: an open-label extension trial of ORION-3/9/10/11 to assess long-term efficacy and safety of twice-yearly inclisiran in patients with high cardiovascular risk and elevated LDL-C. Abstract presented at: European Society of Cardiology; August 25-28, 2023; Amsterdam, Netherlands. 10. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020(supplement):1-31. 11. Wright RS. A pooled safety analysis of inclisiran in 3576 patients with approximately 10,000 person-years of exposure from seven trials. Oral presentation at: American College of Cardiology Annual Conference; March 2023; New Orleans, LA. 12. Data on file. LEQVIO 3-Year Shelf Life. Novartis Pharmaceuticals Corp; 2022. 13. Data on file. LEQVIO Container Closure System. Novartis Pharmaceuticals Corp; 2022. 14. Repatha. Prescribing information. Amgen Inc. 15. Khvorova A. Oligonucleotide therapeutics—a new class of cholesterol-lowering drugs. N Engl J Med. 2017;376(1):4-7. doi:10.1056/NEJMp1614154 16. Fitzgerald K, White S, Borodovsky A, et al. A highly durable RNAi therapeutic inhibitor of PCSK9. N Engl J Med. 2017;376:41-51. doi:10.1056/NEJMoa1609243 17. McClellan M, Brown N, Califf RM, Warner JJ. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American Heart Association. Circulation. 2019;139(9):e1-e11. doi:10.1161/CIR.0000000000000652 18. Jacobson TA, Cheeley MK, Jones PH, et al. The STatin Adverse Treatment Experience Survey: experience of patients reporting side effects of statin therapy. J Clin Lipidol. 2019;13(3):415-424. 19. Jones PH, Nair R, Thakker KM. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012;1(6):1-10. doi:10.1161/JAHA.112.001800 20. Maningat P, Gordon BR, Breslow JL. How do we improve patient compliance and adherence to long-term statin therapy? Curr Atheroscler Rep. 2013;15(1):291. 21. Mann DM, Woodward M, Muntner P, Falzon L, Kronish I. Predictors of nonadherence to statins: a systematic review and meta-analysis. Ann Pharmacother. 2010;44(9):1410-1421. doi:10.1007/s11883-012-0291-7 22. Benner JS, Glynn RJ, Mogun H, et al. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002;288(4):455-461. 23. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421. 24. Cannon CP, deLemos JA, Rosenson RS. Use of lipid-lowering therapies over 2 years in GOULD, a registry of patients with atherosclerotic cardiovascular disease in the US. JAMA Cardiol. 2021;6(9):1060-1068. doi:10.1001/jamacardio.2021.1810 25. Fox KM, Tai M-H, Kostev K, Hatz M, Qian Y, Laufs U. Treatment patterns and low-density lipoprotein cholesterol (LDL-C) goal attainment among patients receiving high- or moderate-intensity statins. Clin Res Cardiol. 2018;107(5):380-388. doi:10.1007/s00392-017-1193-z 26. Wong ND, Young D, Zhao Y, et al. Prevalence of the American College of Cardiology/American Heart Association statin eligibility groups, statin use, and low-density lipoprotein cholesterol control in US adults using the National Health and Nutrition Examination Survey 2011-2012. J Clin Lipidol. 2016;10(5):1109-1118. 27. Data on file. PCSK9 Discontinuation. Novartis Pharmaceuticals Corp; 2023. 28. Hines DM, Rane P, Patel J, Harrison DF, Wade RL. Treatment patterns and patient characteristics among early initiators of PCSK9 inhibitors. Vasc Health Risk Manag. 2018;14:409-418. doi:10.2147/VHRM.S180496 29. Data on file. Novartis Pharmaceuticals Corp; 2019. 30. Data on file. ORION-8 (CKJX839A12306B) Cumulative LEQVIO exposure. Novartis Pharmaceuticals Corp; 2023.