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PRA.21.10.0002

PRALUENT significantly reduced LDL-C in adults with FH

PRALUENT provided a powerful, sustained reduction in LDL-C in patients with HeFH, when added to maximally tolerated statins1,2

Primary endpoint (ODYSSEY FH I and FH II pooled):
Mean percent change in LDL-C from baseline to Week 24

Treatment difference at Week 24 between PRALUENT and placebo in mean LDL-C change from baseline

-54
%
(95% CI: -59%,
-50%; P<0.0001)

See the study design

PRALUENT patients with HeFH saw improvements in other lipid parameters1

Change in baseline in lipid parameters (ODYSSEY FH I and FH II pooled)1†

At 24 Weeks, patients with HeFH on PRALUENT experienced substantial differences in reductions vs placebo in other measured lipid parameters1:

  • Total cholesterol -36% (95% CI: -39%, -33%)
  • Non-HDL-C -49% (95% CI: -53%, -45%)
  • Apo B -42% (95% CI: -45%, -39%)

†A pattern-mixture model approach was used with multiple imputation of missing post-treatment values based on a patient's own baseline value and multiple imputation of missing on-treatment values based on a model including available on-treatment values.

‡Dose was up-titrated to 150 mg Q2W in 196 (42%) patients treated for at least 12 weeks.

VIEW LDL-C DATA FROM ODYSSEY OUTCOMES
VIEW ADDITIONAL LDL-C DATA

When added to other lipid-lowering therapies,

PRALUENT provided a robust reduction in LDL-C in adults with HoFH

ODYSSEY HoFH primary endpoint: Mean percent change
in LDL-C from baseline to Week 12 in patients with HoFH1,3

Treatment difference at Week 12 between PRALUENT and placebo in mean LDL-C change from baseline

-36
%
(95% CI: -51%,
-20%; P<0.0001)

See the study design

PRALUENT patients with HoFH experienced improvements across other lipid parameters1,3

Effect of PRALUENT on lipid parameters in patients with HoFH (percent change from baseline to Week 12)1

At 12 Weeks, patients with HoFH on PRALUENT saw substantial differences in reductions in LS mean vs placebo across all measured lipid parameters1,3:

  • Apo B -30% (95% CI: -42%, -17%)
  • Non-HDL-C -33% (95% CI: -48%, -18%)
  • Total cholesterol -27% (95% CI: -39%, -14%)

Patients with 2 LDL-receptor negative alleles (little to no residual function) had a minimal to absent response to PRALUENT.1

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Despite multiple therapies, adults with FH had elevated LDL-Cs at baseline before starting PRALUENT1,2

Patient baseline characteristics and demographics in HeFH and HoFH trials

  • ||Number of patients on PRALUENT (n=490) compared to placebo (n=245).
  • Number of patients on PRALUENT (n=45) compared to placebo (n=24).
  • #The diagnosis of HoFH was made by either clinical diagnosis, which included a history of an untreated total cholesterol concentration >500 mg/dL together with either xanthoma before 10 years of age or with a history of total cholesterol >250 mg in both parents, or by genetic testing.
  • **In ODYSSEY HoFH, 14% of patients were on lomitapide.

For both HeFH studies and the HoFH study: Patients were taking a maximally tolerated dose of statin with or without other lipid-modifying therapy and required additional LDL-C reduction.1

FH I and FH II (Studies 4 and 5) were 2 multicenter, placebo-controlled, double-blind trials that compared PRALUENT (n=490) with placebo (n=245). The trials were similar with regard to both design and eligibility criteria. All patients had HeFH, were taking a maximally tolerated dose of statin with or without other lipid-modifying therapy, and required additional LDL-C reduction. Patients started on PRALUENT 75 mg every two weeks in addition to existing statin therapy: Up-titration to 150 mg every two weeks occurred at Week 12 in patients (42%) who did not achieve their predefined target LDL-C (<70 mg/dL) at Week 8.1,2

Study 11 (ODYSSEY HoFH) was a multicenter, double-blind, placebo-controlled trial in adults that compared PRALUENT 150 mg every 2 weeks (n=45) and placebo (n=24). Randomization was stratified by LDL apheresis treatment status. The diagnosis of HoFH was made by either clinical diagnosis, which included a history of an untreated total cholesterol concentration >500 mg/dL together with either xanthoma before 10 years of age or with a history of total cholesterol >250 mg in both parents, or by genetic testing.1

Apo B = apolipoprotein B; FH = familial hypercholesterolemia; HDL-C = high-density lipoprotein cholesterol; HeFH = heterozygous familial hypercholesterolemia; HoFH = homozygous familial hypercholesterolemia; LDL-C = low-density lipoprotein cholesterol.

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INDICATIONS AND USAGE

PRALUENT® (alirocumab) is indicated:

  • to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
  • as an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C.
  • as an adjunct to other LDL-C-lowering therapies in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Important Safety Information
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia (including heterozygous familial hypercholesterolemia (HeFH)) (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.
  • The most commonly occurring adverse reactions in the cardiovascular outcomes trial (>5% of patients treated with PRALUENT and occurring more frequently than placebo) were non-cardiac chest pain, nasopharyngitis, and myalgia.
  • In the primary hyperlipidemia (including HeFH) clinical trials, local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.
  • The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively). The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms.
  • In a cardiovascular outcomes trial, local injection site reactions were reported in 3.8% of patients treated with PRALUENT versus 2.1% patients treated with placebo, and led to permanent discontinuation in 0.3% of patients versus <0.1% of patients, respectively.
  • In the primary hyperlipidemia trials, liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo.
  • In the primary hyperlipidemia trials, the most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).
  • PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.
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Important Safety Information
  • PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity reactions, including hypersensitivity vasculitis, angioedema, and other hypersensitivity reactions requiring hospitalization, have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia (including heterozygous familial hypercholesterolemia (HeFH)) (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions, and influenza.
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