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Prescribing information

 

LEQVIO®▼ (inclisiran)

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LEQVIO® is recommended by NICE, within its licensed indication, as an option for the treatment of eligible adult patients who:4

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Find out how to start LEQVIO® in primary and secondary care

Nearly 1 in 5 patients with cardiovascular disease do not have a recorded current prescription of lipid-lowering therapy, remaining at high risk for cardiovascular events and death‡5

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.2,3

 

Learn more about the unmet needs of patients with ASCVD

On average, LDL-C levels were reduced by ~50% from baseline (2.92 ±1.2 mmol/L) in eligible patients with ASCVD on LEQVIO® and a maximally tolerated statin in an observational study, which is consistent with the placebo-corrected results seen in the Phase III trials, ORION-9, ORION-10 and ORION-111,6–8

Discover more findings from ORION-8

In clinical trials, LEQVIO® had a safety profile similar to placebo, apart from injection-site reactions (8.2% and 1.8% of patients, respectively)2,3

Learn more about the safety data of LEQVIO®

 

 

Footnotes

 

*After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.2,3
†(79.4%). ORION-8 (n=3,274) assessed the long-term efficacy and safety of LEQVIO® in patients who entered an open-label extension after completing either ORION-3, ORION-9, ORION-10 or ORION-11 trials. Patients had a baseline LDL-C of 2.92 mmol/L (± 1.2) and the primary endpoints were the proportion of patients achieving pre-specified LDL-C goals (ASCVD <1.8 mmol/L and ASCVD risk equivalent <2.6 mmol/L) at end of study, and safety. Mean cumulative exposure to LEQVIO® in ORION-8 was 3.7 years with a maximum of 6.8 years.1
‡National CVDPREVENT data covering the period up to March 2022. Data was received from 96.6% of GP practices, including approximately 18 million patients.5

ASCVD, atherosclerotic cardiovascular disease; GP, general practitioner; LDL-C, low-density lipoprotein cholesterol; NICE, National Institute for Health and Care Excellence.

 

References

  1. Wright RS, et al. Oral presentation. ORION-8: Long-term efficacy and safety of twice-yearly inclisiran in high cardiovascular risk patients. ESC Congress 2023. Amsterdam, The Netherlands, 25–28 August 2023.
  2. LEQVIO® Great Britain. Summary of Product Characteristics.
  3. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  4. National Institute for Care and Excellence. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta733/resources/inclisiran-for-treating... [Accessed April 2024].
  5. Healthcare Quality Improvement Partnership. https://www.hqip.org.uk/resource/third-annual-report-cvdprevent/ [Accessed April 2024].
  6. Raal FJ, et al. N Engl J Med 2020;382:1520–1530.
  7. Ray KK, et al. N Engl J Med 2020;382:1507–1519.
  8. Ray KK, et al. Eur Heart J 2022;43(48):5047–5057.

LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.

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UK | April 2024 | 423356
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]