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LEQVIO® (inclisiran) injection 284 mg/1.5 mL

POWERFUL AND CONSISTENT LDL-C REDUCTION1*


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

Pivotal Trials


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

In patients with ASCVD, LEQVIO® demonstrated a 52% LDL-C reduction vs placebo with just 2 HCP-administered doses a year1

Patients with ASCVD demonstrated 52% LDL-C reduction on top of a maximally tolerated statin vs placebo.

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

84% of patients

achieved guideline-recommended LDL-C target <70 mg/dL vs 18% of patients on placebo at month 172,3

 

Results were similar in patients with ASCVD or those at increased risk of CVD1

Study Design: ORION-10 (N=1561) and ORION-11 (N=1617) were multicenter, double-blind, randomized, placebo-controlled, 18-month, phase 3 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 percentage change in LDL-C from baseline to day 510.1,4
 

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

LEQVIO demonstrated consistent reduction across predefined subgroups5,6

In the ORION-1 phase 2 study, LDL-C reduction was apparent within 14 days after the first dose of LEQVIO1,7

 

Study Design: ORION-1 was a phase 2, 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

See how the adherence of LEQVIO compares with PCSK9 mAbs

ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; HCP, health care provider; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; LS, least squares; mAb, monoclonal antibody; PCSK9, proprotein convertase subtilisin/kexin type 9; T2DM, type 2 diabetes mellitus.
References: 1. Leqvio. Prescribing information. Novartis Pharmaceuticals Corp. 2. 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. 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. 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;382(16):1507-1519. doi:10.1056/NEJMoa1912387 5. Data on file. Novartis Pharmaceuticals Corp; 2020. 6. 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 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