Q4 2021 Results slide image

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 iptacopan - CFB inhibitor - HEM Study Indication Phase Patients Primary Outcome Measures Arms Intervention Target Patients Read-out Milestone(s) Publication NCT04558918 APPLY-PNH (CLNP023C12302) Paroxysmal nocturnal haemoglobinuria Phase 3 91 Percentage of participants achieving a sustained increase in hemoglobin levels of >= 2 g/dL in the absence of red blood cell transfusions Percentage of participants achieving sustained hemoglobin levels >= 12 g/dL in the absence of red blood cell transfusions Arm 1: Drug: LNP023, taken orally b.i.d. dosage supplied: 200 mg dosage form: hard gelatin capsule Route of Administration: Oral Arm 2: Drug: Eculizumab, administered as intravenous infusion every 2 weeks as per the stable regimen, the maintenance dose is a fixed dose. Dosage supplied: 300 mg/30mL Dosage form: Concentrate solution for infusion Drug: Ravulizumab, administered as intravenous infusion every 8 weeks, the maintenance dose is based on body weight. Dosage Supplied: 300 mg/30mL Dosage f Adult patients with PNH and residual anemia, despite treatment with an intravenous Anti-C5 antibody Primary 2022 Risitano AM, et al. Abstract accepted at the European Hematology Association (EHA 2021) congress (study design abstract; accepted for publication only) NCT04820530 APPOINT-PNH (CLNP023C12301) Paroxysmal nocturnal haemoglobinuria Phase 3 40 Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ? 2 g/dL assessed, in the absence of red blood cell transfusions Iptacopan (LNP023), taken orally b.i.d. (dosage supplied: 200mg) PNH patients who are naive to complement inhibitor therapy, including anti-C5 antibody 2023 Peffault de Latour R, et al. Abstract accepted at the European Hematology Association (EHA 2021) congress (study design abstract; accepted for publication only) 136 Investor Relations | Q4 2021 Results U NOVARTIS | Reimagining Medicine
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