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June 2021
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New Zolgensma data demonstrate age-appropriate development when used presymptomatically and rapid, clinically meaningful efficacy in symptomatic children, even those with severe SMA at baseline
All children (100%) treated presymptomatically in the SPR1NT two-copy cohort survived without respiratory or nutritional support, and sat independently for ≥30 seconds, most (11/14) within the WHO… -
Novartis investigational oral therapy iptacopan (LNP023) shows benefit as monotherapy in treatment-naïve patients with rare and life-threatening blood disorder paroxysmal nocturnal hemoglobinuria
First-in-class, oral, targeted factor B inhibitor iptacopan substantially reduced both intra- and extravascular hemolysis when given as monotherapy in a Phase II study of anti-C5 naïve paroxysmal… -
Novartis announces new interim analysis Phase II data for iptacopan in rare kidney disease C3 glomerulopathy (C3G)
Data shows investigational iptacopan improved estimated glomerular filtration rate (eGFR) slope and stabilized kidney function in patients with C3G1; Phase III clinical trial to start in 2021… -
Novartis announces iptacopan met Phase II study primary endpoint in rare kidney disease IgA nephropathy (IgAN)
Phase II primary endpoint results for investigational iptacopan in IgAN demonstrated effective and clinically meaningful reduction of proteinuria1 – a key risk predictor in kidney disease… -
Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC
Tabrecta® (capmatinib) showed a median overall survival (OS) of 20.8 months in treatment-naïve patients and 13.6 months in previously-treated patients in first published mature data1,2 Tabrecta… -
Novartis investigational checkpoint inhibitor tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer after systemic therapy
Tislelizumab demonstrated a 30% reduction in the risk of death and extended median overall survival by 2.3 months compared to chemotherapy in advanced or metastatic esophageal squamous cell carcinoma… -
Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera
At final analysis, study showed clinically relevant improvement in median overall survival with a difference of 11.7 months between arms (Hazard ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30,… -
Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study
Men who received 177Lu-PSMA-617 plus best standard of care had a 38% reduction in risk of death (median OS benefit of 4 months) and a 60% reduction in the risk of radiographic disease progression or… -
Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma
Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion1Robust response observed in heavily pretreated patients in… -
Novartis Kisqali® reports longest median overall survival in postmenopausal HR+/HER2- metastatic breast cancer patients
MONALEESA-3 median overall survival (OS) results of 53.7 months underscore that Kisqali offers more life to postmenopausal women with HR+/HER2- metastatic breast cancer (MBC) in addition to the OS… -
Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx® as a potential treatment in a JIA population at EULAR 2021
Phase III JUNIPERA study met its primary endpoint, with Cosentyx® (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs. placebo (P<.001) in pediatric… -
Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis
Approval for moderate to severe pediatric patients six years and older is based on pivotal trial data showing Cosentyx demonstrated superior improvements of skin symptoms compared to placebo1…
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