Reimagining Medicine
Company overview
Financial review
Conclusions
Innovation: Pipeline overview
Financial performance
Cardiovascular
Immunology
LeqvioⓇ - siRNA (regulation of LDL-C)
NCT03705234 ORION-4 (CKJX839B12301)
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
References
Leqvio® - siRNA (regulation of LDL-C)
NCT03814187 ORION-8 (CKJX839A12305B)
Hyperlipidemia
Indication
Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH)
Indication
Phase
Phase 3
Phase
Phase 3
Patients
Primary
Outcome
Measures
15000
A composite of major adverse cardiovascular events, defined as:
Coronary heart disease (CHD) death;
Patients
3275
Primary
Outcome
Measures
Myocardial infarction;
Arms
Intervention
Target Patients
Fatal or non-fatal ischaemic stroke; or
Urgent coronary revascularization procedure
Arm 1: every 6 month treatment Inclisiran sodium 300mg (given by
subcutaneous injection on the day of randomization, at 3 months and then
every 6-months) for a planned median duration of about 5 years
Arm 2: matching placebo (given bysubcutaneous injection on the day of
randomization, at 3 months and then every 6 months) for a planned median
duration of about 5 years.
Patient population with mean baseline LDL-C ≥ 100mg/dL
Arms
Intervention
Target
Patients
Readout
Milestone(s)
Publication
Readout
Milestone(s)
2026
Publication
TBD
46 Investor Relations | Q2 2023 Results
Abbreviations
Other
Proportion of subjects achieving prespecified low density lipoprotein cholesterol
(LDL-C) targets at end of study
Safety and tolerability profile of long-term use of inclisiran
Inclisiran sodium 300mg on Day 90 and every 180 days for a planned duration
of 3 years
Patients with HeFH or pre-existing atherosclerotic cardiovascular disease
(ASCVD) on background statin +/- ezetimibe therapy and risk equivalents
(patients from ORION 3, 9, 10 & 11 studies)
2023
A pooled safety analysis of inclisiran in 3576 patients with approximately
10,000 person-years of exposure from seven trials; oral presentation;
ACC 2-4 Mar 2023
NOVARTIS | Reimagining MedicineView entire presentation