Sanofi and Regeneron Pharmaceuticals, Inc.recently 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 will be 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 (https://accscientificsession.acc.org/features/2018/03/video-sanofi-regeneron).
Key findings include:
“This trial was consistent with earlier statin trials, showing the greatest benefit in patients with higher cholesterol levels at baseline,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. “Many patients who have survived a recent heart attack or other coronary event are unable to reach an LDL cholesterol goal of less than 100 mg/dL, and have an urgent need for new therapeutic options because of their increased risk of another event. In this trial, such patients who received Praluent on top of maximally-tolerated statins had important reductions in their risk.”
“Not all patients with heart disease are the same. Through this trial, we have been able to identify high-risk patients treated with optimal statins who still have an urgent need for additional treatment options,” said Elias Zerhouni, M.D., President, Global R&D, Sanofi. “With nearly 90 percent of the patients in this trial on high-intensity statins, the data demonstrate that a precision-medicine approach in the field of cardiovascular disease may further advance how we better treat high-risk patients.”
Investor Relations Conference Call on ODYSSEY OUTCOMES
Sanofi and Regeneron will be hosting a conference call for the financial community on ODYSSEY OUTCOMES. The conference call will take place on Saturday, March 10, 2018 (18:00 CET / 12:00 EST / 09:00 PST).
For more information, visit www.sanofi.com and www.regeneron.com through a webcast.
Conference call numbers are as follows:
United States: +1 (1) 631 570 56 13
France: +33 (0)1 7091 8706
United Kingdom: +44 (0) 207 107 0613
Europe: +41 (0) 58 310 50 00
Other international numbers available here (https://media.choruscall.ch/documents/Attended_DI_numbers.pdf).
About Odyssey Outcomes
ODYSSEY 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, 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 (n=2,615). Some patients who switched to 150 mg switched back to 75 mg if their LDL-C fell below 25 mg/dL (n=805), and patients who experienced two consecutive LDL-C measurements below 15 mg/dL while on the 75 mg dose (n=730) stopped active Praluent therapy for the remainder of the trial.
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 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).
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.
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.
About Regeneron Pharmaceuticals, Inc
Regeneron 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 more information, visit www.regeneron.com.
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, 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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