Regeneron Pharmaceuticals, Inc. (REGN) to Present New Analyses from the Praluent® (alirocumab) Injection ODYSSEY Clinical Trial Program

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Regeneron and Sanofi to Present New Analyses from the Praluent® (alirocumab) Injection ODYSSEY Clinical Trial Program at the AHA Scientific Sessions 2017

New analyses from the ODYSSEY ESCAPE trial evaluating treatment of Praluent in high-risk patients with heterozygous familial hypercholesterolemia (HeFH) undergoing apheresis therapy will be presented. Additional ODYSSEY clinical trial program data include a post-hoc analysis of three pooled ODYSSEY Phase 3 studies evaluating efficacy and safety data by race and ethnicity, and results of the ODYSSEY Open-Label Extension study observing long-term adherence to Praluent.

Key poster presentations at AHA Scientific Sessions 2017 from the ODYSSEY clinical trial program and other studies include:

Praluent Data

  • Characteristics of Patients with <15% Reduction in Low-Density Lipoprotein Cholesterol with Alirocumab (Bays)
  • Effect of Apheresis on Alirocumab and PCSK9 Concentrations in the ODYSSEY ESCAPE Study (Moriarty)
  • Impact of Age on the Efficacy and Safety of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia (Santos)
  • High Level of Adherence to Alirocumab and Concomitant Background Treatments for Patients with Heterozygous Familial Hypercholesterolemia in the ODYSSEY Open-Label Extension Study (Farnier)
  • Alirocumab Efficacy and Safety by Race and Ethnicity: Analysis From Three ODYSSEY Phase 3 Trials (Ferdinand)
  • Predictive Factors of the Magnitude of Response to Alirocumab Dose Increase in Patients with Dyslipidemia (Ray)

Other Data of Interest

  • PCSK9 Inhibitors: Patient-Reported Barriers to Medication Initiation & Persistence (Navar)
  • Statin Utilization and Side Effects Among Adults Over Age 75: Insights From the PALM Registry (Nanna)
  • Associations of Provider Knowledge and Beliefs Regarding Lipid Management With Statin Therapy Use and Lipid Outcomes (Lowenstern)
  • Statin Decision-Making Since the 2013 AHA/ACC Cholesterol Guidelines: Do Clinicians Do What They Say? (Lowenstern)

Additional information on the AHA Scientific Sessions 2017 is available on the meeting website.

About Praluent
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL-C levels in the blood.

Praluent is approved in more than 50 countries worldwide, including the U.S., JapanCanadaSwitzerlandMexico and Brazil, as well as the European Union (EU). In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not been determined. ODYSSEY OUTCOMES is prospectively evaluating the effect of Praluent on the occurrence of CV events in approximately 18,000 patients who have experienced an acute coronary syndrome.

Important Safety Information for the U.S.
Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent.

Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Talk to your doctor about the right way to prepare and give yourself a Praluent injection and follow the “Instructions for Use” that comes with Praluent.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for the full Prescribing Information

About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, and provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

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