Novartis Q4 Results
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Company overview
Financial review
Conclusions
Appendix
Innovation: Pipeline overview
Financial performance
Innovation: Clinical trials
> Cardiovascular, Renal
and Metabolic
Immunology
Neuroscience
Oncology
Other
Global Health
Abbreviations
References
LeqvioⓇ - siRNA (regulation of LDL-C)
LeqvioⓇ - siRNA (regulation of LDL-C)
NCT03705234 ORION-4 (CKJX839B12301)
Indication
Phase
Patients
Primary
Outcome
Measures
Arms
Intervention
Target Patients
NCT05030428 VICTORION-2P (CKJX839B12302)
Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH)
Indication
Phase 3
16124
A composite of major adverse cardiovascular events, defined as:
Coronary heart disease (CHD) death;
Myocardial infarction;
Fatal or non-fatal ischaemic stroke; or
Urgent coronary revascularization procedure
Arm 1: every 6 months 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
Phase
Patients
Primary
Outcome
Measures
Arms
Intervention
Target Patients
Readout
Milestone(s)
Publication
Secondary prevention of cardiovascular events in patients with elevated levels of
LDL-C
Phase 3
16970
1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular
Events)
Arm 1: Experimental Inclisiran sodium, Subcutaneous injection
Arm 2: Placebo Comparator, Placebo Subcutaneous injection
Participants with established cardiovascular disease (CVD)
2027
TBD
Readout
Milestone(s)
2026
Publication
TBD
□ NOVARTIS Reimagining Medicine
Novartis Q4 Results | January 31, 2024
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