Regeneron (REGN), Sanofi (SNY) Present Praluent Phase 3 Data in Lowering LDL-C

November 11, 2016 9:02 AM EST

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Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Sanofi (NYSE: SNY) announced that data from the Praluent (alirocumab) Injection ODYSSEY clinical trial program will be presented at the American Heart Association's (AHA) Scientific Sessions 2016 in New Orleans, Louisiana, from November 12-16.

Analyses of pooled data from the pivotal Phase 3 ODYSSEY clinical trial program include a presentation on the ability for patients to attain their LDL cholesterol goals with Praluent versus ezetimibe. An analysis from the ODYSSEY CHOICE I trial evaluating Praluent as a monthly (every four weeks) dose will also be presented. Other data presentations evaluate the real world use or potential health impact of PCSK9 inhibitors and other lipid-lowering therapies.

Praluent is a PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. Praluent is contraindicated in patients with a history of a serious hypersensitivity reaction to Praluent. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.

Sanofi and Regeneron data is featured in 16 abstracts at the AHA Scientific Sessions 2016. Key data highlights include:

Praluent data:

1) ORAL PRESENTATION

  • Metabolic Syndrome, Dysglycemia, and Dyslipidemia: Diagnostic, Prognostic, and Therapeutic Aspects
    • Pharmacodynamic Relationship Between PCSK9, Alirocumab, and LDL-C Lowering in the ODYSSEY CHOICE I Trial (Roth)
      • Abstract # 685
      • Monday, November 14, 2:00-2:05 p.m. CT (Science and Technology Hall, Population Science Theater)

2) POSTER PRESENTATIONS

  • Preventive Interventions: Population and Clinical Trials
    • Treatment Effect of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia With Baseline Low-density Lipoprotein Cholesterol Levels >130 mg/dL Receiving High Intensity Statin (Kastelein)
      • Abstract # M2013
      • Monday, November 14, 10:45 a.m.-12:00 p.m. CT (Science and Technology Hall, Population Science Section)
    • Comparison of Low-density Lipoprotein Cholesterol Threshold Attainment With Alirocumab versus Ezetimibe Treatment in the ODYSSEY Program (Cannon)
      • Abstract # M2014
      • Monday, November 14, 10:45 a.m.-12:00 p.m. CT (Science and Technology Hall, Population Science Section)

Additional data of interest:

1) ORAL PRESENTATION

  • Risk Assessment and Prevention
    • Impact of Communication Format and Risk Horizon on Patient Perceptions of CVD Risk: Findings From the PALM Registry (Navar)
      • Abstract # 781
      • Tuesday, November 15, 12:20-12:25 p.m. CT (Science and Technology Hall, Population Science Theater)

2) POSTER PRESENTATIONS

  • Epidemiology and Population Studies in Cardiovascular Disease Session I
    • From Clinical Trial to Clinical Setting: What are the Observed Prescribing Behaviors in the United States Since the Launch of PCSK9 Inhibitors? (Karalis)
      • Abstract # S2167
      • Sunday, November 13, 3:45-5:00 p.m. CT (Science and Technology Hall, Population Science Section)
  • Epidemiology and Population Studies: Statins and Statin Adherence
    • Simulation of Impact on Cardiovascular Events With Lipid-lowering Treatment Intensification in Patients With Atherosclerotic Cardiovascular Disease in the US (Cannon)
      • Abstract # T2014
      • Tuesday, November 15, 10:45 a.m.-12:00 p.m. CT (Science and Technology Hall, Population Science Section)

Further information on AHA Scientific Sessions 2016 is available on the congress website.



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