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Unstoppable commitment to ASCVD care for over 10 years

Author : Sanofi
Editorial team

ASCVD is the world's biggest killer.1
To take it on, we need to be nothing less than unstoppable.

Since PRALUENT*'s (alirocumab) approval by the EMA in 2015,2 to this very day, we have been working collectively with patients and healthcare professionals against ASCVD.

Between unstoppably investigating LDL-C reduction and CV event prevention, constant innovation, and continuous collaboration with healthcare professionals to bridge gaps in lipid management, being unstoppable has taken us far.3-8

But it's only just the start.

*Primary hypercholesterolaemia and mixed dyslipidaemia : Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease - Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

 

Unstoppable_evidence_generation

Since PRALUENT's first approval, we've been unstoppably generating evidence to better understand its efficacy and safety profile across various ASCVD populations:3-7

30.9 percent

2015-2020 - ODYSSEY phase 3 programme

The ODYSSEY phase 3 programme - encompassing 11 distinct phase 3 trials - investigated PRALUENT's impact on LDL-C reduction and CV outcomes across high-risk populations.3,10-20

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2020 - SYDNEY device study and CHOICE I

The SYDNEY device study and CHOICE I trial investigated PRALUENT 300 mg once-monthly in high-risk populations.4,5

Analysis_icon

2025 - ODYSSEY post hoc pooled analysis

The pooled analysis of phase 3 ODYSSEY studies assessed PRALUENT's effect on LDL-C reduction in ASCVD patients who had not yet experienced a first CV event.6

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2026 ongoing - OPTIMUS programme

Through the OPTIMUS programme, we're continuing to explore treatment approaches in ASCVD management with real-world and simulation studies utilising advanced methodologies.7,9*

*RWE studies can vary substantially in their methodological approaches, which may contribute to heterogeneity or unexpected findings across analyses. Ensuring that key epidemiological principles - such as appropriate time-zero definition, new-user design considerations, handling of open claims data, and assessment of potential time-related biases - are rigorously applied remains essential to generating reliable insights. High-quality RWE therefore depends on robust and methodologically advanced approaches such as propensity score matching and G-computation used in the studies.

 

Unstoppable_innovation
Innovation_people_images

Over the last decade, we've remained committed to the patient and HCP experience by unstoppably innovating.

In 2016, the PRALUENT 300 mg once-monthly dose was approved in the EU.21 Then, with the release and development of devices like SYDNEY and the Next-Gen pen, PRALUENT became and remains the only PCSK9i with a once-monthly single injection in a pre-filled pen.22*

 

Unstoppable_collaboration
Collaboration_image

Through initiatives like the ACS EuroPath programme, we've been unstoppably identifying gaps in LDL-C management and working with cardiologists to help bridge them.8

With surveys conducted in 2018, 2022 and 2024, we've been able to gain insights into how lipid management has changed over the years and where there are still opportunities for improvement.8 By collaborating with cardiologists on dyslipidaemia guideline implementation, we've also shown how enhanced guideline adherence can help improve outcomes for ACS patients.8

Key findings from our latest ACS EuroPath programme include

Lipid_management_icon

Lipid management of ACS patients has continuously improved from 2018 to 2024.8

Suboptimal_LDL-C_goal_icon

Suboptimal LDL-C goal attainment persists, emphasising need for sustained efforts to help improve outcomes for ACS patients.8

cardiologists_icon

Training cardiologists on dyslipidaemia guidelines helped improve outcomes for patients.8

2024 ACS EuroPath programme
For_over_10_years_graphic

For over 10 years, we've never paused in making progress against ASCVD

We've been unstoppably generating evidence. Unstoppably innovating. Unstoppably collaborating with healthcare professionals to help improve outcomes for patients.3-8,22

But it's only just the start.
Here's to the next 10 years being unstoppable against ASCVD.
Are you coming with us?

NAME OF THE MEDICINAL PRODUCT: Praluent 75 mg, 150 mg or 300 mg solution for injection in pre-filled pen. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each single-use pre-filled pen contains 75 mg alirocumab in 1 ml solution, 150 mg alirocumab in 1 ml solution or 300 mg in 2 ml solution. THERAPEUTIC INDICATIONS: Primary hypercholesterolaemia and mixed dyslipidaemia Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia and in paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) 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. Established atherosclerotic cardiovascular disease  Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: - in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. POSOLOGY AND METHOD OF ADMINISTRATION: Prior to initiating alirocumab secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded. The recommended alirocumab doses are 75 mg once every 2 weeks, 150 mg once every 2 weeks, 300 mg once every 4 weeks (monthly), administered subcutaneously. All doses may be used for initiation of treatment. The dose of alirocumab can be individualized based on patient characteristics such as baseline LDL-C level, goal of therapy, and response. Lipid levels can be assessed 4 to 8 weeks after treatment initiation or titration, and dose adjusted accordingly (up-titration or down-titration). Intense LDL-C reduction is expected with alirocumab 150 mg once every 2 weeks and 300 mg once every 4 weeks (monthly), where 150 mg once every 2 weeks is the maximum dose. If a dose is missed, the patient should administer the injection as soon as possible and thereafter resume treatment on the original schedule. No dose adjustment is needed for elderly patients, or patients with mild or moderate hepatic or renal impairment, in patients based on weight. Alirocumab has not been studied in paediatric patients less than 8 years of age. Method of administration Subcutaneous injection into the thigh, abdomen or upper arm. Each pre-filled pen is for single use only. To administer the 300 mg dose, either one 300 mg injection or two 150 mg injections should be given consecutively at two different injection sites. It is recommended to rotate the injection site with each injection. Alirocumab should not be injected into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections. Alirocumab must not be co-administered with other injectable medicinal products at the same injection site.  The patient may either self-inject alirocumab, or a caregiver may administer alirocumab, after guidance has been provided by a healthcare professional on proper subcutaneous injection technique. The solution should be allowed to warm to room temperature prior to use. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Allergic reactions General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies. Angioedema has been reported in the postmarketing setting. If signs or symptoms of serious allergic reactions occur, treatment with alirocumab must be discontinued and appropriate symptomatic treatment initiated. Renal impairment In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 ml/min/1.73 m2). Alirocumab should be used with caution in patients with severe renal impairment. Hepatic impairment Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Alirocumab should be used with caution in patients with severe hepatic impairment. UNDESIRABLE EFFECTS: The most common adverse reactions, at recommended doses, are local injection site reactions (6.1%), upper respiratory tract signs and symptoms (2.0%), and pruritus (1.1%). Most common adverse reactions leading to treatment discontinuation in patients treated with alirocumab were local injection site reactions. MARKETING AUTHORISATION HOLDER: Sanofi Winthrop Industrie 54, rue La Boétie F-75008 Paris, France. DATE OF REVISION OF THE TEXT: October 17th 2025. Medicinal product subject to restricted medical prescription. Detailed information on this medicine is available on European Medicines Agency website http://www.ema.europa.eu

SWEDEN
PRESCRIPTION MEDICATION. Reimbursement: Reimbursed for  patients with diagnosed heterozygous familial hypercholesterolemia who, despite maximal tolerable treatment with statin and ezetimibe, have persistent LDL cholesterol of 2.6 mmol/L or higher. Reimbursed  for patients with diagnosed atherosclerotic cardiovascular disease who, despite maximal tolerable treatment with statin and ezetimibe, have persistent LDL cholesterol of 1.8 mmol/L or higher. Reimbursed for patients with diagnosed diabetes mellitus and target organ damage (microalbuminuria, retinopathy, or neuropathy), or at least three major risk factors, or early onset of type 1 diabetes mellitus with long duration, who, despite maximal tolerable treatment with statin and ezetimibe, have persistent LDL cholesterol of 2.6 mmol/L or higher. C10AX14.The SmPC is available on www.fass.se. In Sweden Praluent is provided by Sanofi AB, Box 300 52, 104 25 Stockholm, tel +46 8 634 50 00. For questions on our medicinal products, please contact infoavd@sanofi.com.

ACS = acute coronary syndrome; ASCVD = atherosclerotic cardiovascular disease; CV = cardiovascular; EMA = European Medicines Agency; EU = European Union; HCP = healthcare professional; LDL-C = lowdensity lipoprotein cholesterol; PCSK9i = proprotein convertase subtilisin/kexin type 9 inhibitor; RWE = real-world evidence.

 

  1. Ray KK, Ference BA, Séverin T, et al. World Heart Federation cholesterol roadmap 2022. Glob Heart. 2022;17(1):75.

  2. European Medicines Agency. Praluent. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/praluent#assessment-history. Last accessed June 2026.

  3. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097–2107.

  4. Frias JP, Koren MJ, Loizeau V, et al. The SYDNEY device study: a multicenter, randomized open-label usability study of a 2-mL alirocumab autoinjector device. Clin Ther. 2020;42(1):94–107.

  5. Roth EM, Moriarty PM, Bergeron J, et al. A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I. Atherosclerosis. 2016;254:254–262.

  6. Castro Cabezas M, Orsini M, Tokgözoglu L, et al. Efficacy and safety of alirocumab in patients with established atherosclerotic vascular disease before their first cardiovascular event: pooled analysis of phase 3 ODYSSEY studies. J Clin Lipidol. 2026;20(1):44–55.

  7. Bhatt DL, Perrone Filardi P, Khan I, et al. PCSK9 inhibitor treatment and outcomes in patients with atherosclerotic cardiovascular disease but without prior ischaemic events: an observational study. Eur Heart J. 2026;00:1–10.

  8. Laufs U, De Caterina R, Schiele F, et al. The ACS EuroPath survey series: time trends in lipid management after an acute coronary syndrome. Eur J Prev Cardiol. 2025;zwaf399.

  9. Steen DL, Ray KR, Khan I, et al. Guideline-Based Lipid-Lowering Therapy in Acute Coronary Syndromes: A Simulation of Population-Level Impact on Cardiovascular Events and LDL-C Goal Achievement. 2026;14:S1933-2874(26)00074-7.

  10. Blom DJ, Harada-Shiba H, Rubba P, et al. Efficacy and Safety of Alirocumab in Adults With Homozygous Familial Hypercholesterolemia. J Am Coll Cardiol. 2020;76(2):131–142.

  11. Cefalu AB, Garbelotto R, Mombelli G, et al. A subgroup analysis of the ODYSSEY APPRAISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022;32:2638–2646.

  12. Farnier M, Hovingh GK, Langslet G, et al. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY programme. Atherosclerosis. 2018;278:307–314.

  13. Gaudet D et al. Safety and efficacy of alirocumab in a real-life setting: the ODYSSEY APPRISE study. European Journal of Preventive Cardiology. 2022;28(17):1864–72.

  14. Han Y, Chen J, Chopra VK, et al. ODYSSEY EAST: Alirocumab efficacy and safety vs ezetimibe in high cardiovascular risk patients with hypercholesterolemia and on maximally tolerated statin in China, India, and Thailand. J Clin Lipidol. 2020;14:98–108.

  15. Leiter LA, Cariou B, Muller-Wieland D, et al. Efficacy and safety of alirocumab in insulin-treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The ODYSSEY DM-INSULIN randomized trial. Diabetes Obes Metab. 2017;19:1781–1792.

  16. Moriarty PM, Parhofer KG, Babirak SP, et al. Alirocumab in patients with heterozygous familial hypercholesterolaemia undergoing lipoprotein apheresis: the ODYSSEY ESCAPE trial. Eur. Heart J. 2016;37:3588–3595.

  17. Moriarty PM, Jacobson TA, Bruckert E, et al. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. J Clin Lipidol. 2014;8:554–561.

  18. Ray KK et al. (2018). Alirocumab vs usual lipid-lowering care as add-on to statin therapy in individuals with type 2 diabetes and mixed dyslipidaemia: The ODYSSEY DM-DYSLIPIDEMIA randomized trial. Diabetes Obes Metab. 20(6):1479–89.

  19. Stroes E, Guyton JR, Lepor N, et al. Efficacy and Safety of Alirocumab 150 Mg Every 4 Weeks in Patients With Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II study. J Am Heart Assoc. 2016;5:e003421.

  20. Teramoto T, Kiyosue A, Ishigaki Y, et al. Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin: ODYSSEY NIPPON. Cardiol. 2019;73:218–227.

  21. PR Newswire. Sanofi and Regeneron announce FDA approval of a new once-monthly dosing option for Praluent® (alirocumab) injection. Available at: https://www.prnewswire.com/news-releases/sanofi-and-regeneron-announce-fda-approval-of-a-new-once-monthly-dosing-option-for-praluent-alirocumab-injection-300445096.html. Last accessed June 2026.

  22. PRALUENT (alirocumab) Summary of Product Characteristics. Paris, France: sanofi-aventis groupe; 10/2025

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