WELL-TOLERATED SAFETY PROFILE¹

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

*Includes 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

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 3 clinical trials^1,4
• No new safety signals⁴

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.

ASCVD, atherosclerotic cardiovascular disease; CVD, cardiovascular disease; HeFH, heterozygous familial hypercholesterolemia; LDL-C, low-density lipoprotein cholesterol; T2DM, type 2 diabetes mellitus.