Novartis' heart failure medicine LCZ696 granted FDA priority review
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Novartis' heart failure medicine LCZ696 granted FDA priority review
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* Decision could speed access to LCZ696 for HFrEF patients in the US, reducing
total review time from 12 to 8 months
* Filing is based on results from the landmark PARADIGM-HF study[1]
* Nearly six million people live with heart failure in the US, and despite
current therapies, up to 50% of patients die within five years of
diagnosis[2],[3]
Basel, February 13, 2015 - Novartis announced today that the US Food and Drug
Administration (FDA) has granted priority review designation to LCZ696, an
investigational medicine for the treatment of heart failure with reduced
ejection fraction (HFrEF). The designation accelerates the review of therapies
that offer a significant improvement in the safety or effectiveness of the
treatment, prevention or diagnosis of a serious condition[4]. For LCZ696 this
reduces the total review time from 12 to 8 months, meaning the FDA could make a
decision on approval in August 2015.
"LCZ696 is a demonstration of our commitment to developing innovative medicines
that improve important heart failure related outcomes such as cardiovascular
mortality, hospitalization and quality of life," said David Epstein, Division
Head, Novartis Pharmaceuticals. "The FDA's decision reflects the significant
need to extend and improve life for HFrEF patients and Novartis is working to
ensure LCZ696 can become available in the US as soon as possible."
The New Drug Application (NDA) was submitted under the agency's Fast Track
program and is based on results from the landmark PARADIGM-HF study, the largest
ever conducted in heart failure[1], which showed LCZ696 was superior to ACE-
inhibitor enalapril on key endpoints, including significantly reducing the risk
of CV death or heart failure hospitalization. Patients' reports of how well they
felt were significantly better with LCZ696 than enalapril, whilst maintaining an
acceptable safety profile.
In the EU the Committee for Medicinal Products for Human Use (CHMP) has granted
accelerated assessment to LCZ696.
About LCZ696 in heart failure
LCZ696, a twice a day medicine being investigated for heart failure, has a
unique mode of action which is thought to reduce the strain on the failing
heart[1]. It acts to enhance the protective neurohormonal systems of the heart
(NP system) while simultaneously suppressing the harmful system (the RAAS).
Currently available medicines for HFrEF primarily block the harmful effects and
mortality remains very high with up to 50% of patients dying within 5 years of a
diagnosis of heart failure[3],[5],[6].
Heart failure is a debilitating and life-threatening disease in which the heart
cannot pump enough blood around the body. Symptoms such as breathlessness,
fatigue and fluid retention can appear slowly and worsen over time,
significantly impacting quality of life[7].
It is a significant and growing public health concern with a high unmet need for
new treatments. Every year, HF costs the world economy $108 billion, and
hospitalizations comprise 60-70% of direct treatment costs[8],[9],[10].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "priority review," "could," "investigational," "commitment,"
"can," "being investigated," "thought," "growing," or similar terms, or by
express or implied discussions regarding potential marketing approvals for
LCZ696, or regarding potential future revenues from LCZ696. 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 LCZ696
will be approved for sale in any market, or submitted for approval in any
additional markets, or at any particular time. Neither can there be any
guarantee that LCZ696 will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Nor can there
be any guarantee that LCZ696 will be commercially successful in the future. In
particular, management's expectations regarding LCZ696 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 manufacturing 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, cost-saving generic pharmaceuticals, preventive vaccines and over-the-
counter products. Novartis is the only global company with leading positions in
these areas. In 2014, the Group achieved net sales of USD 58 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 130,000 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 (at)Novartis at
http://twitter.com/novartis.
References
[1] McMurray JJV, Packer M, Desai AS, et al. Angiotensin-neprilysin inhibition
versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004. doi:
10.1056/NEJMoa1409077.
[2] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke
Statistics - 2015 Update: A Report from the American Heart Association.
Circulation. 2015;131:00-00.
[3] Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence
and survival in a community-based population. JAMA. 2004;292:344-350.
[4] U.S. Food and Drug Administration. Priority Review.
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm. Updated September
15, 2014. Accessed January 27, 2015.
[5] Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the
management of heart failure: A report of the American College of Cardiology
Foundation/American Heart Association task force on practice guidelines.
Circulation. 2013;128:e240-e327.
[6] Langenickel TH, Dole WP. Angiotensin receptor-neprilysin inhibition with
LCZ696: a novel approach for the treatment of heart failure. Drug Discovery
Today: Therapeutic Strategies. 2012;9(4):e131-e139. doi:
10.1016/j.ddstr.2013.11.002.
[7] Fauci A, Longo D. Disorders of the Heart. Harrison's 'Principles of Internal
Medicine. 17th ed. 2008;4:1442-55.
[8] Cook C, Cole G, Asaria P et al, The annual global economic burden of heart
failure. Int J Cardiol. 2014.;171(3):368-76
[9] Neumann T, Biermann J, Erbel R et al, Heart failure: the commonest reason
for hospital admission in Germany: medical and economic perspectives. Dtsch
Arztebl Int. 2009;106:269-75.
[10] Stewart S, Jenkins A, Buchan S et al, The current cost of heart failure to
the National Health Service in the UK. Eur J Heart Fail. 2002 Jun;4(3):36-71.
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Datum: 13.02.2015 - 17:30 Uhr
Sprache: Deutsch
News-ID 371612
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