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WELL-TOLERATED SAFETY PROFILE1

In LEQVIO Phase III clinical trials over 18 months, most common adverse reactions in ≥3% of patients treated with LEQVIO and more frequently than placebo1

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aIncludes related terms such as injection site pain, erythema, and rash.

2.5% of patients discontinued LEQVIO vs 1.9% with placebo1

  • Injection site reactions were the most common causes for treatment discontinuation (0.2% of patients taking LEQVIO vs 0% taking placebo)1

The safety profile of LEQVIO was consistent across all subgroups, including elderly, hepatic, and renally impaired patient populations1*

The majority of adverse events were mild to moderate in severity1,11,29

*LEQVIO was not studied in patients with end-stage renal disease or severe hepatic impairment.

No contraindications, warnings and precautions, or clinically significant drug-drug
interactions expected as per the prescribing information.1

CONSISTENT SAFETY PROFILE
BEYOND 6 YEARS1,8†

In ORION-8, an open-label extension study in patients with ASCVD or at increased risk of CVD (N=3274):

  • LONG-TERM SAFETY DATA WERE CONSISTENT WITH PHASE III CLINICAL TRIALS1,8

  • NO NEW SAFETY SIGNALS1,8

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

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

Study Description: 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.

THERE'S MORE TO
KNOW ABOUT LEQVIO

Effective and sustained LDL-C reduction is
possible for your patients1‡

STUDY CLINICAL DATA arrow

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

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION AND IMPORTANT SAFETY
INFORMATION

COLLAPSE

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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.