Q2 2021 Results - Reimagining Medicine
Participants
Financial performance
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
References
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Oncology
Ophthalmology
Respiratory
Sandoz Biopharmaceuticals
Global Health
Abbreviations
EntrestoⓇ
(ARNI)
-
Angiotensin II Receptor Neprilysin Inhibitor
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
NCT03066804 PARALLAX (CLCZ696D2302)
Heart failure, preserved ejection fraction
Phase 3
2572
Change in NT-proBNP from baseline to week 12
and change in 6 minute walk distance (6MWD) from baseline to Week 24
Sacubitril/valsartan 50 mg, 100 mg and 200 mg bid and matching placebo
Enalapril 2.5 mg, 5 mg and 10 mg bid and matching placebo
Valsartan 40 mg, 80 mg, 160 mg bid and matching placebo
Heart failure patients (NYHA Class II-IV) with preserved ejection fraction
Target Patients
Read-out Milesstone(s)
2019 (actual)
Publication
Primary data publication in High Tier Journal 2021
NCT03785405 (CLCZ696B2319E1 - extension study)
Heart failure in pediatric patients
Phase 3
240
Number of participants with Adverse Events (AEs) and Serious Adverse Events
(SAEs)
Single arm, open label sacubitril/valsartan (pediatric formulation granules (12.5,
31.25 mg in capsules); liquid formulation (1mg/ml and 4mg/ml concentration) and
adult formulation (50, 100, 200 mg bid))
Pediatric patients with heart failure due to systemic left ventricle systolic dysfunction
who have completed study CLCZ696B2319
2023
TBD
60 Investor Relations | Q2 2021 Results
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