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 enalapril1
· Heart failure is a life-threatening condition affecting nearly 15 million Europeans2; about half have the reduced ejection fraction form3
Basel, November 24, 2015 – Novartis announced today that the European Commission (EC) has approved Entresto™ (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 enalapril1. 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 properly4. 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.
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, Entresto1:
- 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 group1.
The foregoing release contains forward-looking statements that can be identified by words such as "hope," "offer," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Entresto, or regarding potential future revenues from Entresto. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Entresto will be submitted or approved for sale in any market, or at any particular time. Nor can there be any guarantee that Entresto will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding Entresto could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety issues; unexpected manufacturing or quality issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.