Novartis (CH)

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07.08

Novartis (CH) Novartis (CH)

Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p<0.0001) 1 Fabhalta is an inhibitor of...

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29.07

Novartis (CH) Novartis (CH)

Novartis Scemblix® granted FDA Priority Review for the treatment of adults with newly diagnosed CML

P riority Review based on ASC4FIRST Phase III study with Scemblix ® data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard of care therapies (imatinib and 2G...

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31.05

Novartis (CH) Novartis (CH)

Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease

Addition of Kisqali ® (ribociclib) to endocrine therapy (ET) demonstrated a 28% risk reduction in invasive disease-free survival (iDFS) in subgroup of patients with node-negative (N0) disease at high risk of recurrence 1 Patients with N0 disease...

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31.05

Novartis (CH) Novartis (CH)

Novartis Scemblix® Phase III data first to show superior efficacy with a favorable safety and tolerability profile vs. standard-of-care TKIs in adults with newly diagnosed CML

Phase III ASC4FIRST trial met both primary endpoints with clinically meaningful and statistically significant results; Scemblix ® (asciminib) demonstrated superior MMR rates at week 48 vs. investigator-selected SoC TKIs (imatinib, nilotinib,...

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25.05

Novartis (CH) Novartis (CH)

Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo

Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo 1 ; additional 6-month open-label data to be presented at a future medical meeting 2,3 Fabhalta showed a favorable...

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25.05

Novartis (CH) Novartis (CH)

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36...

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15.05

Novartis (CH) Novartis (CH)

Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA

Primary results of the Scemblix ® ASC4FIRST pivotal Phase III study in first-line Ph+ CML-CP supporting third US FDA Breakthrough Therapy designation, to be detailed in the ASCO Press Program and the EHA Plenary Session Latest data from the...

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23.04

Novartis (CH) Novartis (CH)

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric (ages 12-17) and adult patients Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare cancer...

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17.04

Novartis (CH) Novartis (CH)

Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment-naïve people with relapsing multiple sclerosis

Continuous Kesimpta® treatment for up to six years showed sustained efficacy in recently diagnosed (≤3 years) treatment-naïve people living with relapsing multiple sclerosis (RMS) in an analysis of the ALITHIOS open-label extension study 1 Similar...

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15.04

Novartis (CH) Novartis (CH)

New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)

APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN 1 IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic...

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