For LDL-C reduction in patients with primary hyperlipidemia along with diet and statin therapy¹

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

Most common adverse reactions with LEQVIO

^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 populations^1*

The majority of adverse events were mild to moderate in severity^1-3

*LEQVIO was not studied in patients with end-stage renal disease or severe hepatic impairment.¹

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

CONSISTENT SAFETY PROFILE BEYOND 6 YEARS^4†

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 Trials^1,4
No New Safety Signals⁴

^†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.^4,5
^‡Factors that increase risk of CVD include HeFH, T2DM, or 10-year risk of ≥20%.⁶

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.⁴

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 patients^1§

STUDY CLINICAL DATA

ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; T2DM, type 2 diabetes mellitus
^§Greater LDL-C reduction was maintained during each 6-month dosing interval vs placebo as a complement to a maximally tolerated statin.¹

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

2.5% of patients discontinued LEQVIO vs 1.9% with placebo¹

The safety profile of LEQVIO was consistent across all subgroups, including elderly, hepatic, and renally impaired patient populations^1*

The majority of adverse events were mild to moderate in severity^1-3

CONSISTENT SAFETY PROFILE BEYOND 6 YEARS^4†

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

THERE’S MORE TO KNOW ABOUT LEQVIO

IMPORTANT SAFETY INFORMATION

INDICATION

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

2.5% of patients discontinued LEQVIO vs 1.9% with placebo1

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 severity1-3

CONSISTENT SAFETY PROFILE BEYOND 6 YEARS4†

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

THERE’S MORE TO KNOW ABOUT LEQVIO

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

2.5% of patients discontinued LEQVIO vs 1.9% with placebo¹

The safety profile of LEQVIO was consistent across all subgroups, including elderly, hepatic, and renally impaired patient populations^1*

The majority of adverse events were mild to moderate in severity^1-3

CONSISTENT SAFETY PROFILE BEYOND 6 YEARS^4†

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