Swissmedic approves Novartis' new heart failure medicine Entresto(TM)

Decision by Swiss Health Authority follows US Food and Drug Administration (FDA) approval of Entresto in July, serves as an important reference approval for multiple other health authorities

Entresto is  indicated in Switzerland to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction

People with heart failure face high risk of death and poor quality of life, with only half alive 5 years after diagnosis[1],[2]
Basel, September 18, 2015 - Novartis announced today that Swissmedic has approved Entresto(TM) (sacubitril/valsartan), previously known as LCZ696, to reduce the risk of cardiovascular mortality and morbidity in patients with heart failure with reduced ejection fraction (HFrEF). Entresto will be available on prescription for adult patients whose condition is classified NYHA class II-IV and with an ejection fraction of 40% or less. It is administered in combination with other heart failure therapies as appropriate, in place of an ACE inhibitor or angiotensin receptor blocker.

"This is another significant milestone and good news for HFrEF patients in Switzerland who will shortly be able to benefit from Entresto, helping them live longer and stay out of hospital", said David Epstein, Division Head, Novartis Pharmaceuticals.

As a key stage of Entresto manufacture happens in Switzerland and it is an important reference country for Novartis, the Swissmedic approval is particularly important as it enables multiple Health Authorities around the world to complete their review of Entresto. Swissmedic's decision 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.[3] 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.

Approximately 150,000 people in Switzerland live with heart failure[4] and about half have the reduced ejection fraction form.[5] Heart failure is a debilitating, life-threatening condition in which the heart cannot pump enough blood around the body. Patients face a high risk of death, repeated hospitalizations and symptoms such as breathlessness, fatigue and fluid retention significantly impacting their quality of life.[6]

About Entresto
Entresto is a first in class medicine (an ARNI, 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).[7]

Results from the 8,442 patient PARADIGM-HF study showed, versus enalapril, Entresto:[3]
- 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.[3]

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "will," "shortly," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or new indications or labeling 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 any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that Entresto will be submitted or approved for sale in any additional markets or at any particular time. Nor can there be any guarantee that Entresto will 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 and reimbursement issues; 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.

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 http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis (link is external).

References
[1] Loehr LR, Rosamond WD, Chang PP, Folsom AR, Chambless LE. Heart failure incidence and survival (from the Atherosclerosis Risk in Communities study). Am J Cardiol. 2008;101(7):1016-1022
[2] Lloyd-Jones et al. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010;121:e46-215
[3] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med 2014
[4] Hullin R. LCZ 696 - a promising new compound in heart failure treatment.. Cardiovascular Medicine 2015
[5] Mozaffarian D, et al. Heart Disease and Stroke Statistics - 2015 Update: A Report From the American Heart Association. Circulation. 2014
[6] Mosterd A, Hoes, A, Clinical epidemiology of heart failure, Heart 2007;93:1137-1146
[7] 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

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