If subsequently approved, Entresto will be the first and only approved therapy for the treatment of symptomatic chronic heart failure patients aged 1 to <18 years in the European Union Pediatric heart failure is an important cause of childhood morbidity and mortality – up to a third of all pediatric […]
Tag: Novartis
FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year
– With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) – Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin […]
Novartis delivers solid Q3 results, with strong growth in Innovative Medicines. Announces strategic review of Sandoz
Ad hoc announcement pursuant to Art. 53 LR Q3 net sales grew +5% (cc¹, +6% USD) Innovative Medicines grew +7% (cc, +8% USD) Strong performance of key growth drivers: Entresto (+44% cc), Cosentyx (+22% cc), Kesimpta (USD 109 million), Jakavi (+26% cc), Zolgensma (+28% cc), Promacta/Revolade (+18% cc) and Kisqali (+27% cc) Sandoz declined -2% (cc, -1% USD), affected by continued pricing pressures. Ex-US […]
World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio® ▼(inclisiran)
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England1 Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a […]
Novartis Entresto® granted expanded indication in chronic heart failure by FDA
Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined heart failure to include both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3 Expanded indication enables potential treatment of more adults with […]
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF) Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use in treatment of patients with both major types of […]
New Novartis analyses for investigational inclisiran demonstrate consistently effective and sustained LDL-C reduction at month 17, regardless of age and gender
Pooled data analyses from Phase III ORION-9, -10 and -11 showed that inclisiran consistently reduced low-density lipoprotein cholesterol (LDL-C) by approximately 51% in both male and female adult patients and in three age categories1,2 Sustained LDL-C reduction with inclisiran was observed regardless of age or gender differences with two doses […]
New Novartis analyses for investigational inclisiran demonstrate consistently effective and sustained LDL-C reduction at month 17 regardless of age and gender
Pooled data analyses from Phase III ORION-9, -10 and -11 showed that inclisiran consistently reduced low-density lipoprotein cholesterol (LDL-C) by approximately 51% in both male and female adult patients and in three age categories1,2 Sustained LDL-C reduction with inclisiran was observed regardless of age or gender differences1,2 with two doses a year, after an initial […]
Novartis receives positive CHMP opinion for Leqvio®* (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients with hypercholesterolemia or mixed dyslipidemia1 Cardiovascular disease (CVD) claims 3.9 million lives annually in Europe2, and 80% of high-risk patients do not reach guideline-recommended low-density lipoprotein cholesterol (LDL-C) targets despite the widespread use of statins3–5 Inclisiran provides effective and sustained reduction of LDL-C of up to […]
Novartis US Foundation commits $25M to improve health equity by reducing health disparities in the US
Building on $10M+ commitments to date, US Foundation is providing up to an additional $15M due to emergence of COVID-19 pandemic and elevated focus on social injustice Commitment to include partnerships and support to address the underrepresentation of minorities, including African American/Black and Hispanic communities, in clinical trials Reinforces US […]
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