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 […]
Tag: Novartis
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 […]
Novartis Agrees to Pay $678 Million to Settle Allegations of Illegal Kickbacks Involving Several of the Company’s Cardiovascular Drugs
Attorney Eric L. Young Represents Whistleblower Oswald Bilotta in One of the Largest Ever Recoveries in a Health Care Fraud Case Brought Under the Qui Tam Provisions of the False Claims Act PHILADELPHIA, July 01, 2020 (GLOBE NEWSWIRE) — Attorney Eric. L. Young announced today that Novartis Pharmaceuticals Corporation (“Novartis”) has agreed to settle alleged […]
Novartis new analysis further showed durable and potent LDL-C reduction with inclisiran, an investigational first-in-class siRNA cholesterol-lowering treatment
EAST HANOVER, N.J., March 28, 2020 /PRNewswire/ — Novartis today announced results from a prespecified analysis of pooled data from three Phase III studies evaluating the safety and efficacy of inclisiran, its first-in-class investigational treatment for hyperlipidemia in adults. The data was presented during a Late Breaker session at the American College of […]
Novartis announces NEJM publication of three pivotal trials showing durable and potent efficacy of inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy
– Inclisiran, an investigational medicine, showed durable and potent reduction of low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH)[1,2] – Inclisiran reduced LDL-C at 17 months by 52% in patients with ASCVD (ORION-10), 50% for ASCVD and ASCVD risk […]
Novartis successfully completes acquisition of The Medicines Company, adding a potentially first-in-class, investigational cholesterol-lowering therapy inclisiran
Over 50 million secondary prevention patients worldwide with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) on current standard of care do not achieve LDL cholesterol (LDL-C) goal and remain at increased risk of cardiovascular events1 The Medicines Company submitted the New Drug Application (NDA) for inclisiran to the FDA […]
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