For adults with HeFH on maximally tolerated statin therapy,

Repatha® Was Studied in Patients With HeFH Who Require Additional Lipid Lowering1,2

Study 3

Study 3 study design Study 3 study design

In a multicenter, double-blind, randomized, placebo-controlled trial:

  • Adult patients (18-80 yrs) with a clinical diagnosis of HeFH requiring additional LDL-C lowering†, ‡ were randomized to Repatha® or placebo1,2

  • Primary endpoint was percent change from baseline in LDL-C at week 122

  • Post-lipid stabilization period baseline characteristics:1

- Mean age = 51

- Mean baseline LDL-C = 156 mg/dL

- Gender = 42% female, 58% male

- All patients were taking statin therapy

- Atherosclerotic CVD = 38%

- High-intensity statin = 76%

– Mean age = 51

– Gender = 42% female, 58% male

– Atherosclerotic CVD = 38%

– Mean baseline LDL-C = 156 mg/dL

– All patients were taking statin therapy

– High-intensity statin = 76%

*Baseline was measured after the lipid stabilization period and before administration of first dose of study drug, n = 329.1

At screening, eligible patients included those with HeFH diagnosed by the Simon Broome diagnostic criteria on a stable statin dose with or without other approved lipid-modifying therapy for at least 4 weeks before screening.2

Use of LDL or plasmapheresis within 16 weeks prior to enrollment and treatment with fibrates within 6 weeks of treatment were not allowed. Patients were stratified by other, non-statin lipid-lowering therapy and LDL-C level prior to randomization; in adults, the Simon Broome criteria include an LDL-C of > 190 mg/dL (without therapy) plus clinical criteria (including patient or family history of tendon xanthomas, plus either family history of early CAD or family history of total cholesterol > 290 mg/dL).2,3

Repatha® Every 2 Weeks + a Statin Helped Patients Escape High LDL-C, With 61% Greater LDL-C Reduction Than Statin Alone1

Study 3

Study 3 results Study 3 results
  • Repatha® every 2 weeks helped up to 68% of patients achieve LDL-C < 70 mg/dL2

  • Repatha® once monthly lowered LDL-C an additional 60% when combined with background therapy1

Background therapy was statin therapy with or without other lipid-lowering therapies.

Mean baseline was 156 mg/dL.1

References: 1. Repatha® (evolocumab) Prescribing Information, Amgen. 2. Raal FJ, Stein EA, Dufour R, et al. Lancet. 2015;385:331-340. 3. Scientific Steering Committee on behalf of the Simon Broome Register Group. Br Med J. 1991;303:893-896.

IMPORTANT SAFETY INFORMATION

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Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha®.

Allergic reactions: Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha®, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hyperlipidemia, including HeFH: The most common adverse reactions (> 5% of Repatha®-treated patients and occurring more frequently than placebo) in clinical trials in primary hyperlipidemia (including HeFH) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2% of Repatha®-treated patients and 1% of placebo-treated patients. The most common adverse reaction that led to Repatha® treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3% versus 0% for Repatha® and placebo, respectively).

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha®-treated patients and placebo-treated patients were 0.1% and 0%, respectively.

Allergic reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common allergic reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse reactions in the Cardiovascular Outcomes trial: The safety profile of Repatha® in this trial was generally consistent with the safety profile described above in the 12- and 52-week controlled trials involving patients with primary hyperlipidemia (including HeFH). Serious adverse events occurred in 24.8% and 24.7% of Repatha®-treated and placebo-treated patients, respectively. Adverse events led to discontinuation of study treatment in 4.4% of patients assigned to Repatha® and 4.2% assigned to placebo. Common adverse reactions (>5% of patients treated with Repatha® and occurring more frequently than placebo) included diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients assigned to Repatha® compared with 7.7% in those assigned to placebo.

Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with Repatha®.

Please see full Prescribing Information.

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