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A FIRST-IN-CLASS siRNA
LIPID–LOWERING
THERAPY THAT
TARGETS THE LIVER1

LEQVIO® PREVENTS
FORMATION OF PCSK9
PROTEIN, ALLOWING MORE
LDL RECEPTORS TO REMOVE
CIRCULATING LDL-C1

Works selectively in the liver1,15

  • Harnesses the body's process of RNA interference, which is restricted to the cytoplasm15,16

  • No impact on DNA15,16

Reaches undetectable levels in circulation within 48 hours of administration1

  • Half-life of 9 hours; no accumulation with multiple dosing1

Prevents the production of PCSK9 protein with an extended duration of effect1,15,16

  • Is slowly released into the cytoplasm and loads onto the RNA-induced silencing complex (RISC)15,16

  • Once loaded, works with RISC to sequentially cleave multiple copies of PCSK9 protein mRNA, which continuously prevents PCSK9 production1,15

  • Less PCSK9 allows for increased LDL-C receptors to bind to and decrease circulating LDL-C1


mRNA, messenger ribonucleic acid; siRNA, small interfering ribonucleic acid.

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THERE'S MORE TO
KNOW ABOUT LEQVIO

Gain insights into LEQVIO safety

SEE SAFETY PROFILE arrow

LDL-C, low-density lipoprotein-cholesterol; PCSK9, proprotein convertase subtilisin/kexin type 9.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY
INFORMATION

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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.