TARRYTOWN, N.Y. and BRIDGEWATER, N.J., Nov. 11, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today 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:
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.
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 cholesterol levels in the blood. Praluent is the only PCSK9 inhibitor available in two dosages with two levels of efficacy (75 mg and 150 mg), allowing physicians to select the dose based on a patient's LDL cholesterol lowering needs.
Praluent is approved in approximately 40 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the U.S., Praluent is approved for use as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. In the E.U., 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 cholesterol 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 yet 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.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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.
Please click here for the full Prescribing Information
About Sanofi Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc. Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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