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Press Release

Praluent (alirocumab) significantly reduced risk of cardiovascular events in high-risk patients, and was associated with lower death rate, shows new data

Sanofi
Posted on: 12 Mar 18

 

  • The ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating that high-risk patients who used Praluent® (alirocumab), on top of their maximally-tolerated statin dose, experienced significantly fewer major adverse cardiovascular events, such as heart attacks and strokes, compared to those on statins alone1
  • More pronounced effect observed in patients with baseline LDL-C levels at or above 100 mg/dL, despite maximally-tolerated statins, who are at high risk of suffering a future event; in this group, alirocumab reduced risk of major adverse cardiovascular events by 24% and was associated with a 29% lower risk of death overall1
  • In this 18,924-patient, long-term trial, the safety profile of alirocumab was consistent with previous trials and no new safety issues were observed.1

 

Guildford. — March 10, 2018 – Sanofi 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 or stroke.1

 

Results from the trial were 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:

  • On the primary endpoint, alirocumab reduced the overall risk of MACE by 15% (HR=0.85, CI: 0.78-0.93, p=0.0003). The MACE composite endpoint includes patients who experienced a heart attack, ischemic stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalisation1
  • Alirocumab was also associated with a lower risk of death overall, known as “all-cause mortality” (HR=0.85; CI: 0.73-0.98, nominal p=0.026), and while not statistically significant, there were also fewer coronary heart disease (CHD) deaths (HR=0.92; CI: 0.76-1.11, p=0.38)1
  • In a pre-specified analysis, patients with baseline LDL-C (otherwise known as bad cholesterol) levels at or above 100 mg/dL experienced a more pronounced effect from alirocumab, reducing their risk of MACE by 24% (HR=0.76, CI: 0.65-0.87). In a post-hoc analysis of this group, alirocumab was associated with a lower risk of death from any cause by 29% (HR=0.71, CI: 0.56-0.90)1

 

Data from ODYSSEY OUTCOMES showed alirocumab to have an acceptable safety profile; no new safety concerns were raised by the trial.1

 

“On average, someone dies as a result of cardiovascular disease every three minutes in the UK. There’s a wealth of evidence to show the important role that reducing high levels of bad cholesterol plays in heart attack and stroke prevention, and the ODYSSEY OUTCOMES study data is some of the most promising we’ve seen in this area.” Commented ODYSSEY OUTCOMES UK Principal Investigator, Professor Kausik Ray, Professor of Public Health in the Department of Public Health and Primary Care at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust. “These new results show, for the first time, that use of alirocumab to lower cholesterol can reduce heart attacks and stroke in high-risk patients.” 

 

“At Sanofi, we’re committed to improving the lives of those living with high cholesterol in the UK. We’re therefore extremely encouraged by the results from the ODYSSEY OUTCOMES study. 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 Hubert Bland, Country Medical Chair, Sanofi UK. “Alirocumab is available across the UK on the NHS, but often those that could benefit most from this treatment have not yet been offered it as an option. We hope that the availability of this new evidence will mean more high-risk patients receive alirocumab to support their cholesterol management.”

 

About ODYSSEY OUTCOMES

ODYSSEY OUTCOMES (n=18,924) assessed the effect of alirocumab 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 randomised to receive alirocumab (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.1

 

The trial was designed to maintain patients’ LDL-C levels between 25-50 mg/dL, using two different doses of alirocumab (75 mg and 150 mg). Alirocumab -treated patients started the trial on 75 mg every two weeks, and switched to 150 mg every two 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 alirocumab therapy for the remainder of the trial.1

 

About alirocumab

Alirocumab 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.2 The use of alirocumab to reduce the risk of MACE is investigational and has not been evaluated by any regulatory agency.

 

Alirocumab 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 UK, alirocumab is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • In combination with a statin, or statin with other lipid-lowering therapies, in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin 
  • Or alone, or in combination with other lipid-lowering therapies, in patients who are statin-intolerant, or for whom a statin is contraindicated

The effect of alirocumab on cardiovascular morbidity and mortality has not been determined.3

 

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.

 

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, 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, Empowering Life

 

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

 

References

  1. Gregory G. Schwartz, Michael Szarek, Deepak L. Bhatt, Vera Bittner, Rafael Diaz, Jay Edelberg, Shaun G. Goodman, Corinne Hanotin, Robert Harrington, J. Wouter Jukema, Guillaume Lecorps, Angèle  oryusef, Robert Pordy, Matthew Roe, Harvey D. White, Andreas Zeiher, Ph. Gabriel Steg. The ODYSSEY OUTCOMES Trial: Topline Results Alirocumab in Patients After Acute Coronary Syndrome. Presented at The American College of Cardiology 67th Scientific Sessions; March 10, 2018; Orlando, FL.
  2. Chaudhary R et al. (2017) World J Cardiol; 26:76–91
  3. Sanofi. Summary of Product Characteristics (Praluent). 2016.
Editor's Details

Claire Whitmarsh
Sanofi
www.sanofi.co.uk
+44 7935 503 416
claire.whitmarsh@sanofi.com

Last updated on: 12/03/2018

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