Q4 2021 Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Financial performance
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
LeqvioⓇ - siRNA (regulation of LDL-C)
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milestone(s)
Publication
NCT03851705 ORION-5 (CKJX839A12302)
Hypercholesterolemia inc. Homozygous Familial Hypercholesterolemia (HoFH)
Phase 3
56
LDL-C reduction at Day 150
Changes in PCSK9, other lipids and lipoproteins
Part 1: inclisiran sodium 300mg on Day 1 and Day 90 or placebo on Day 1
and Day 90
Part 2: inclisiran sodium 300mg on Day 180 for patients who were randomized to
the placebo group only, inclisiran sodium 300mg on Day 270 and then every 6
months for a planned duration of 2 years for all patients
Patients with HoFH with background statin +/- ezetimibe therapy
Primary: Q3-2020 (actual); Final: H2-2021
TBD
NCT04652726 ORION-16 (CKJX839C12301)
Hyperlipidemia, pediatrics
Phase 3
150
Percentage (%) change in low-density lipoprotein cholesterol (LDL-C) from baseline
to Day 330
Group 1: Inclisiran sodium 300mg on Days 1, 90, 270, placebo on Day 360, inclisiran
sodium 300mg on Days 450 and 630;
Group 2: Placebo on Days 1, 90, 270, inclisiran sodium 300mg on Days 360,
450 and 630.
Adolescents (12 to less than 18 years) with heterozygous familial
hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C)
2024
TBD
72 Investor Relations | Q4 2021 Results
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