LAVAL, QC, March 10, 2018 /CNW Telbec/ - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the ODYSSEY OUTCOMES trial met its primary endpoint, showing Praluent® (alirocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event such as a heart attack. Results from the trial was presented today during a late-breaker session at the American College of Cardiology's 67th Annual Scientific Session (ACC.18) in Orlando, Florida and are available here.
Key findings include:
About ODYSSEY OUTCOMESODYSSEY OUTCOMES (n=18,924) assessed the effect of Praluent on the occurrence of MACE in patients who had experienced an ACS between 1-12 months (median 2.6 months) before enrolling in the trial, and who were already on maximally-tolerated statins. All patients were randomized to receive Praluent (n=9,462) or a placebo (n=9,462) and were treated for an average (median) of 2.8 years, with some patients being treated for up to five years. Approximately 90% of patients were on a high-intensity statin.
The trial was designed to maintain patients' LDL-C levels between 25-50 mg/dL (0.6 -1.3 mmol/L), using two different doses of Praluent (75 mg and 150 mg). Praluent-treated patients started the trial on 75 mg every 2 weeks, and switched to 150 mg every 2 weeks if their LDL-C levels remained above 50 mg/dL (1.3 mmol/L) (n=2,615). Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (0.6 mmol/L) (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL (0.4 mmol/L) while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial.
About PraluentPraluent 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 lowers LDL-C levels in the blood. The use of Praluent to reduce the risk of MACE is investigational and has not been evaluated by any regulatory agency.
Praluent is approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU).
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.
The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
For the product monograph: http://products.sanofi.ca/en/praluent.pdf
About Regeneron Pharmaceuticals, IncRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists for 30 years, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, including VelocImmune® to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
About SanofiSanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, 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.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi entities in Canada employ close to 1,900 people. In 2016 we invested $130 million in R&D in Canada, creating jobs, business and opportunity throughout the country.
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