Sanofi at ESC Congress 2026 | ASCVD & LDL-C Management

ODYSSEY OUTCOMES: A multicentre, randomised, double-blind, placebo-controlled phase 3 study. Adult patients with a recent MI or UA, and on high-intensity statin (40 mg or 80 mg atorvastatin, or 20 mg or 40 mg rosuvastatin, or maximally tolerated dose of one of these agents) +/- other lipid-lowering therapy, but not at predefined target LDL-C, were enrolled. Patients were randomly assigned to subcutaneous PRALUENT 75 mg (n=9,462) or matching placebo (n=9,462) Q2W. The PRALUENT dose was adjusted under blinded conditions to target an LDL-C level of 25–50 mg/dL (0.6–1.3 mmol/L).^5,6

OPTIMUS-CLASS: retrospective real-world database review aiming to evaluate the impact of PCSK9i mAbs on the primary endpoint (composite of nonfatal MI, nonfatal IS, or all-cause mortality) vs. no PCSK9i (no PCSK9i mAbs [alirocumab or evolocumab] or PCSK9i siRNA [inclisiran]). The study population consisted of patients with ASCVD but without prior ischaemic events. Patients who initiated PCSK9i mAbs (n=6,545) were identified in the US Optum Research Database and propensity score matching was implemented to select a comparable group without any PCSK9i use (n=13,125). Parametric G-formula was used to estimate the expected event rate curves over time for the primary endpoint.⁴

PRALUENT is indicated for:⁶
Primary hypercholesterolaemia and mixed dyslipidaemia
PRALUENT is indicated in adults with primary hypercholesterolaemia (heterozygous familial and nonfamilial) 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.

Abbreviations

ACS = acute coronary syndrome; ARR = absolute risk reduction; ASCVD = atherosclerotic cardiovascular disease; CV = cardiovascular; CVOT = cardiovascular outcomes trial; ESC = European Society of Cardiology; HeFH = heterozygous familial hypercholesterolaemia; IS = ischaemic stroke; LDL-C = low-density lipoprotein cholesterol; LLT = lipid-lowering therapy; mAb = monoclonal antibody; MI = myocardial infarction; PCSK9i = proprotein convertase subtilisin/kexin type 9 inhibitor; Q2W = every 2 weeks; RRR = relative risk reduction; siRNA = small interfering ribonucleic acid; UA = unstable angina; US = United States.

Referanser

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

2. Stark BA, DeCleene NK, Desai EC, et al. Global, regional, and national burden of cardiovascular diseases and risk factors in 204 countries and territories, 1990–2023. J Am Coll Cardiol 2025;86(22):2167–243.

3. Sinning D and Landmesser U. PCSK9 inhibition in patients without previous cardiovascular events but at high risk: the earlier the better. Eur Heart J. 2026;ehag456.

4. 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;ehag176.

5. 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.

6. PRALUENT (alirocumab) Summary of Product Characteristics. Paris, France: sanofi-aventis groupe;

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 17^th 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

NORWAY
Reseptstatus: C Pakninger og priser: Pakninger og priser: 75 mg/ml: 2 stk. (ferdigfylt penn) kr 5 178.40. 6 stk. (ferdigfylt penn) kr 15 462.60. 150 mg/ml: 2 stk. (ferdigfylt penn) kr 5 178.40. 6 stk. (ferdigfylt penn) kr 15 462.60. 300 mg/2 ml: 3 stk. (ferdigfylt penn) kr 15 462.60. Refusjonsprisen er rabattert: Anbudskode: 2580. Refusjonsberettiget bruk https://www.felleskatalogen.no/medisin/blaarev-register/c10ax14-1:

* Gentest må være utført ** Sekundærprofylakse etter akutt koronarsykdom (hjerteinfarkt, ustabil angina med sykehusinnleggelse), koronar- eller annen arteriell revaskularisering, angina pectoris, ischemisk hjerneslag eller symptomatisk perifer arteriell sykdom *** For brukere som tåler statiner: Høyeste tolererbare dose statin i kombinasjon med ezetimib. For brukere som ikke tåler statiner (statinintoleranse): Minst to forskjellige statiner i laveste dose i kombinasjon med ezetimib. Intoleranse må dokumenteres i journal av forskrivende lege. Ved absolutt kontraindikasjon mot statiner: ezetimib i monoterapi. Refusjonskoder ICD: -26 etablert aterosklerotisk sykdom (sekundærprevensjon) og E78 ren hyperkolesterolemi. ICPC: -26 etablerte aterosklerotisk sykdom og T93 hyperkolesterolemi. Lokal representant: sanofi-aventis Norge AS, Prof. Kohts vei 5-17, 1325 Lysaker. Tel: +47 67 10 71 00.  Se Felleskatalogen for mer informasjon.