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
NCT03060577 ORION-3 (CKJX839A12201E1)
Hypercholesterolemia inc. Atherosclerotic Cardiovascular Disease (ASCVD)
and ASCVD risk equivalents Heterozygous Familial Hypercholesterolaemia (HeFH)
Phase 2
490
LDL-C reduction at Day 210 for Group 1 subjects
Changes in other lipids and lipoproteins and reduction of LDL-C of more than 50%
for patients that are above LDL-C goal; longer term exposure and safety.
Group 1 - inclisiran sodium 300mg sc on Day 1 and every 180 days thereafter for
up to 4 years.
Group 2- Evolocumab 140mg s.c. injection on Day 1 and every 2 weeks until Day
336, followed by inclisiran sodium 300mg on Day 360, Day 450 and then every 6
months for a planned duration of 4 years.
Patients with HeFH or pre-existing atherosclerotic cardiovascular disease
(ASCVD) on background statin +/- ezetimibe therapy
Read-out Milestone(s)
2021 (actual)
Publication
TBD
NCT03814187 ORION-8 (CKJX839A12305B)
Hypercholesterolemia inc. Heterozygous Familial Hypercholesterolaemia (HeFH)
and Homozygous Familial Hypercholesterolemia (HoFH)
Phase 3
2991
Proportion of subjects achieving pre specified 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 1 (placebo patients entered into study from ORION
9, 10 & 11) or placebo on Day 1 (inclisiran patients entered into study from ORION
9, 10 & 11) then inclisiran sodium 300mg on Day 90 and every 6 months 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
TBD
71 Investor Relations | Q4 2021 Results
1 NOVARTIS | Reimagining MedicineView entire presentation