TARRYTOWN, N.Y. and BRIDGEWATER, N.J., March 7, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced new Phase 3 data from the Praluent® (alirocumab) Injection clinical trial program will be presented at the American College of Cardiology Scientific Sessions (ACC.17), March 17-19, 2017 in Washington, D.C.
Key data include presentations on the effects of Praluent across several patient subsets such as diabetes, heterozygous familial hypercholesterolemia (HeFH), and atherosclerotic cardiovascular disease (ASCVD) and post-hoc analyses on the effect of Praluent on major cardiovascular events (MACE). Additionally, a safety update utilizing real-world data from the Praluent open-label extension trial will be presented.
Praluent is a human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), which is approved in approximately 40 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). The effect of Praluent on cardiovascular (CV) morbidity and mortality has not yet been determined.
Sanofi and Regeneron data will be presented throughout ACC.17 during the following sessions of note:
1) MODERATED POSTER PRESENTATIONS
- The PCSK9 revolution: new insights into evaluation and treatment
- Alirocumab efficacy and safety in patients with hypercholesterolemia and with or without clinical atherosclerotic cardiovascular disease: Pooled analysis of 10 ODYSSEY randomized trials (Jones)
- Abstract #1133M-03
- Friday, March 17, 10:00 - 10:10 a.m. ET
- Alirocumab treatment in a real world setting: Safety update from an open-label treatment extension to the ODYSSEY program for patients with heterozygous familial hypercholesterolemia (Guyton)
- Abstract #1133M-07
- Friday, March 17, 10:30 - 10:40 a.m. ET
- Impact of statin intolerance rates on ezetimibe and/or PCSK9 inhibitor use for meeting low-density lipoprotein goals in a real-world cohort with atherosclerotic cardiovascular disease (Cannon)
- Abstract #1133M-13
- Friday, March 17, 11:15 - 11:25 a.m. ET
- A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of alirocumab in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their lipid-modifying therapy in South Korea and Taiwan (Koh)
- Abstract #1133M-15
- Friday, March 17, 11:30 - 11:40 a.m. ET
- The intersection of diabetes and atherosclerotic cardiovascular disease (ASCVD)
- Alirocumab safety in individuals with and without diabetes mellitus: Pooled data from 14 ODYSSEY trials (Leiter)
- Abstract #1222M-07
- Saturday, March 18, 1:00 - 1:10 p.m. ET
2) POSTER PRESENTATIONS
- Advances in cholesterol measurement and management
- Efficacy and safety of the PCSK9 inhibitor alirocumab 300 mg every 4 weeks in individuals with type 2 diabetes on maximally tolerated statin therapy (Muller-Wieland)
- Abstract #1106-055
- Friday, March 17, 10:00 - 10:45 a.m. ET
- Traditional and novel factors used to assess the risk of, and used for the treatment of, coronary artery disease (CAD)
- Lower on-treatment low-density lipoprotein cholesterol is associated with lower cardiovascular risk in very high risk patients with atherosclerotic cardiovascular disease: analyses from the ODYSSEY trials (Ray)
- Abstract # 1126-316
- Friday, March 17, 10:00 - 10:45 a.m. ET
- Advances in lipid management
- Alirocumab reduces major cardiovascular events in individuals with atherosclerotic cardiovascular disease: a post-hoc analysis of ODYSSEY LONG TERM (Robinson)
- Abstract #1203-305
- Saturday, March 18, 9:45 - 10:30 a.m. ET
- Use of high-intensity statin therapy post-acute coronary syndrome in the ongoing ODYSSEY OUTCOMES trial of alirocumab, a proprotein convertase subtilisin/kexin type 9 monoclonal antibody, versus placebo: Interim baseline data (Goodman)
- Abstract #1203-307
- Saturday, March 18, 9:45 - 10:30 a.m. ET
- Cardiac arrest, diabetes, and other high risk features of patients with acute coronary syndrome (ACS)
- Lower on-treatment low-density lipoprotein cholesterol is associated with lower cardiovascular risk in women: Analyses from the ODYSSEY trials of alirocumab versus control (Vallejo-Vaz)
- Abstract #1204-331
- Saturday, March 18, 9:45 - 10:30 a.m. ET
Additional information on ACC.17 is available on the congress website.
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.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing Information
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, asthma, atopic dermatitis, 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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thereto, including the patent litigation relating to Praluent® (alirocumab) Injection, the permanent injunction granted by the United States District Court for the District of Delaware that, if upheld on appeal, would prohibit Regeneron and Sanofi from marketing, selling, or manufacturing Praluent in the United States, the outcome of any appeals regarding such injunction, the ultimate outcome of such litigation, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition; the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation
Praluent; unforeseen safety issues and possible liability resulting from the administration of products (including without limitation Praluent) and product candidates in patients; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials, such as the ODYSSEY OUTCOMES trial prospectively assessing the potential of Praluent to demonstrate cardiovascular benefit; ongoing regulatory obligations and oversight impacting Regeneron's marketed products (such as Praluent), research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies (such as the ODYSSEY OUTCOMES trial); determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or
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