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Decision brings hope of longer and better life with fewer hospitalizations for millions of Europeans with symptomatic chronic heart failure with reduced ejection fraction
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Entresto is the first and only treatment to show a significant mortality benefit in a head-to-head trial against ACE-inhibitor enalapril[1]
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Heart failure is a life-threatening condition affecting nearly 15 million Europeans[2]; about half have the reduced ejection fraction form[3]
BASEL, Switzerland I November 24, 2015 I Novartis announced today that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
The approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril[1]. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.
“We know that people living with heart failure face a high risk of death and have a worse quality of life than those with almost any other chronic condition, so it is very meaningful for HFrEF patients in Europe that we’re able to offer a new first in class treatment option,” said David Epstein, Division Head, Novartis Pharmaceuticals.
Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly[4]. As a consequence patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.
Every day 10,000 Europeans are diagnosed with heart failure and 15 million are estimated to live with the condition. Despite the prevalence, most people fail to recognize the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.
About Entresto
Entresto exhibits the mechanism of action of an Angiotensin Receptor Neprilysin Inhibitor that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS)[5].
Results from the 8,442 patient PARADIGM-HF study showed, versus enalapril, Entresto[1]:
– reduced the risk of death from cardiovascular causes by 20%
– reduced heart failure hospitalizations by 21%
– reduced the risk of all-cause mortality by 16%
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.
Fewer patients on Entresto discontinued study medication for any adverse event compared to those on enalapril. The Entresto group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group[1].
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit
References
[1] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med 2014
[2] López-Sendón J. The heart failure epidemic. Medicographia. 2011;33:363-369
[3] Mozaffarian D, et al. Heart Disease and Stroke Statistics – 2015 Update: A Report From the American Heart Association. Circulation. 2014
[4] Mosterd A, Hoes, A, Clinical epidemiology of heart failure, Heart 2007;93:1137-1146
[5] Langenickel TH et al. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discovery Today: Therapeutic Strategies.2012, Vol 9. No.4
SOURCE: Novartis
Post Views: 30
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Decision brings hope of longer and better life with fewer hospitalizations for millions of Europeans with symptomatic chronic heart failure with reduced ejection fraction
-
Entresto is the first and only treatment to show a significant mortality benefit in a head-to-head trial against ACE-inhibitor enalapril[1]
-
Heart failure is a life-threatening condition affecting nearly 15 million Europeans[2]; about half have the reduced ejection fraction form[3]
BASEL, Switzerland I November 24, 2015 I Novartis announced today that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.
The approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril[1]. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril.
“We know that people living with heart failure face a high risk of death and have a worse quality of life than those with almost any other chronic condition, so it is very meaningful for HFrEF patients in Europe that we’re able to offer a new first in class treatment option,” said David Epstein, Division Head, Novartis Pharmaceuticals.
Heart failure is a highly debilitating, life-threatening condition in which the heart cannot pump enough blood around the body because the muscles of the heart become too weak or too stiff to work properly[4]. As a consequence patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention that significantly impact quality of life.
Every day 10,000 Europeans are diagnosed with heart failure and 15 million are estimated to live with the condition. Despite the prevalence, most people fail to recognize the symptoms, meaning many are misdiagnosed or incorrectly attribute the signs to growing older.
About Entresto
Entresto exhibits the mechanism of action of an Angiotensin Receptor Neprilysin Inhibitor that reduces the strain on the failing heart. A twice-a-day tablet, it acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS)[5].
Results from the 8,442 patient PARADIGM-HF study showed, versus enalapril, Entresto[1]:
– reduced the risk of death from cardiovascular causes by 20%
– reduced heart failure hospitalizations by 21%
– reduced the risk of all-cause mortality by 16%
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or time to first heart failure hospitalization.
Fewer patients on Entresto discontinued study medication for any adverse event compared to those on enalapril. The Entresto group had more hypotension and non-serious angioedema but less renal impairment, hyperkalemia and cough than the enalapril group[1].
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit
References
[1] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med 2014
[2] López-Sendón J. The heart failure epidemic. Medicographia. 2011;33:363-369
[3] Mozaffarian D, et al. Heart Disease and Stroke Statistics – 2015 Update: A Report From the American Heart Association. Circulation. 2014
[4] Mosterd A, Hoes, A, Clinical epidemiology of heart failure, Heart 2007;93:1137-1146
[5] Langenickel TH et al. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discovery Today: Therapeutic Strategies.2012, Vol 9. No.4
SOURCE: Novartis
Post Views: 30
