Novartis' serelaxin (RLX030) improved symptoms and mortality across multiple subgroups of patients with acute heart failure[1],[2]
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Novartis International AG /
Novartis' serelaxin (RLX030) improved symptoms and mortality across multiple
subgroups of patients with acute heart failure[1],[2]
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* New analysis of RELAX-AHF published in the European Heart Journal and
presented as a late breaker at the European Society of Cardiology
congress[1],[2]
* If approved, RLX030 has the potential to be the first treatment breakthrough
for AHF patients in 20 years[3],[4]
Basel, September 2, 2013 - Results from a new analysis of the Phase III RELAX-
AHF study published today in the European Heart Journal and presented as a late
breaker at the European Society of Cardiology (ESC) congress in Amsterdam
indicate that the investigational medicine RLX030 consistently improved symptoms
and mortality across multiple subgroups of patients with acute heart failure
(AHF) assessed in the trial[1],[2].
The addition of RLX030 to conventional treatment led to improvements in
breathlessness (dyspnea) and mortality at 6 months across all pre-specified
subgroups including those with renal impairment (eGFR<50ml/min), the elderly
(>=75 years) and patients with atrial fibrillation,[1],[2] although the small
numbers of patients in each group limit the statistical conclusions that can be
drawn. AHF patients require urgent treatment so prompt decision-making to stop
heart failure worsening is crucial in spite of patients often having diverse
clinical profiles.
"Treatment of AHF is largely unchanged since the 1970s and with RLX030 Novartis
aims to bring the first therapy shown to improve longer-term outcomes to
patients," said David Epstein, Division Head of Novartis Pharmaceuticals. "This
new analysis adds to the overall results from RELAX-AHF that showed intervention
with RLX030 is key to halting the downward spiral of organ damage that occurs
during an AHF episode".
Each year around 3.5 million AHF episodes happen in the US and EU alone[5]; this
is expected to increase further as the population ages. Every AHF episode
contributes to a downward spiral of worsening heart failure and damage to vital
organs, such as the heart and kidneys, which decreases the chance of the patient
surviving another episode[6]. There is an urgent need for new treatments that
help relieve patients' symptoms and protect the vital organs against damage
during an AHF episode, as well as have the potential to increase life expectancy
in the AHF patient population.
Results from RELAX-AHF previously presented in 2012 demonstrated that RLX030
reduced the risk of death by more than one-third (37%) compared with
conventional treatment at six months[7]. RLX030 is currently the only drug for
which a reduction in all-cause mortality has been observed in patients with AHF
in a major study[7].
RLX030 is currently being assessed by health authorities around the world
including the US Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) for the treatment of AHF. In June 2013 the FDA granted RLX030
Breakthrough Therapy designation status, recognizing its potential to address a
serious unmet medical need[8].
Study details
Results from the full analysis of RELAX-AHF were presented at the American Heart
Association congress in November 2012. RELAX-AHF was an international
randomized, double-blind study involving 1,161 patients and was designed to
compare the efficacy and safety profile of RLX030 to placebo in addition to
standard therapy for the treatment of AHF. RLX030 was given within 16 hours of
hospitalization (mean 7.8 hours) in the form of an intravenous infusion (30 mcg
per kg per day) for 48 hours in addition to conventional therapy for AHF. The
study had two primary endpoints using different scales to measure reduction in
breathlessness (dyspnea). The visual analog scale (VAS) showed a significant
benefit up to day five (p=0.0075), whereas the Likert scale (a baseline-related
short-term assessment of dyspnea relief) did not reach significance at 6, 12 and
24 hours (p=0.702)[1]. As one of the primary endpoints was met the study was
positive according to protocol criteria[7].
Analysis of additional endpoints showed that patients who received RLX030 had a
37% reduction in the risk of mortality at 6 months after an AHF episode compared
with those who received conventional treatment[7]. RLX030 also significantly
reduced heart failure worsening up to day 14 (p=0.026) thereby decreasing the
need for intensified treatment, as well as reducing the mean length of stay in
hospital by 0.9 days (p=0.039) and in the intensive/cardiac care unit by 0.4
days (p=0.029)[7]. The study did not meet secondary endpoints including days
alive and out of hospital up to day 60 (p=0.438), and cardiovascular death or
re-hospitalization due to heart or kidney failure up to day 60 (p=0.862)[7].
RELAX-AHF showed that the side effects of RLX030 were comparable to conventional
therapy and the drug was generally well tolerated[7].
In this subgroup analysis the effects of RLX030 versus conventional treatment
were similar across multiple pre-specified groups with respect to the primary
dyspnea endpoints, 60-day composite outcomes, and 180-day mortality[1],[2],
although due to the small numbers of patients in each subgroup the study is
underpowered to draw conclusions about individual groups. Subgroups included
age, sex, race, geographic region, estimated glomerular filtration rate, time
from presentation to randomization, baseline systolic blood pressure, history of
diabetes, atrial fibrillation, ischemic heart disease, cardiac devices and
intravenous nitrates at randomization.
About RLX030 and Novartis' commitment to heart failure
RLX030 is a form of a naturally occurring hormone (human relaxin-2), present in
both men and women[9], although its levels rise in pregnant women to help the
body cope with the additional cardiovascular demands during pregnancy[10].
Another Novartis compound called LCZ696, an angiotensin receptor neprilysin
inhibitor, is the first in a new class of drugs being evaluated for the
treatment of chronic heart failure. A robust clinical development program
including two global phase III studies (PARAGON-HF and PARADIGM-HF) is underway
to fully assess the efficacy and safety profile of LCZ696[11],[12].
About heart failure
Heart failure is a debilitating and potentially life-threatening condition where
the heart cannot pump enough blood around the body. More than 20 million people
suffer from heart failure worldwide and this number is increasing[13],[14]. The
condition is often fatal when patients have one or repeated AHF episodes. As an
AHF episode approaches, patients become severely breathless and incapacitated
and may rapidly gain weight due to fluid build-up in the lungs and around the
body. Every AHF episode results in a downward spiral of worsening health and
damage to vital organs, such as the heart and kidneys, which decreases the
chance of the patient surviving another episode[6].
Patients experiencing an AHF episode require immediate treatment, making AHF the
most common cause of hospitalization in patients over 65 years[15],[16]
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "investigational," "aims," "expected,"
"being assessed," "Breakthrough Therapy," "commitment," "being evaluated,"
"underway," or similar expressions, or by express or implied discussions
regarding potential approvals for RLX030 or LCZ696, or regarding potential
future revenues from such products. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of
management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that RLX030 or LCZ696 will
be approved for sale in any market, or at any particular time. Nor can there be
any guarantee that such products will achieve any particular levels of revenue
in the future. In particular, management's expectations regarding such products
could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial results,
including unexpected new clinical data and unexpected additional analysis of
existing clinical data; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; unexpected
manufacturing issues; the impact that the foregoing factors could have on the
values attributed to the Novartis Group's assets and liabilities as recorded in
the Group's consolidated balance sheet, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. 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
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
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References
[1] Metra et al. Administration of serelaxin to patients with acute heart
failure: are there any differences across RELAX-AHF subgroups? Clinical Trial
Update Hot Line I: Updates on hypertension, heart failure and diabetes; Abstract
3478. European Society of Cardiology 2013.
[2] Metra et al. Effects of serelaxin in subgroups of patients with acute heart
failure: results from RELAX- AHF. Eur Heart J 2013 Sept 2; ePub ahead of print
(doi: 10.1093/eurheartj/eht371).
[3] Cowie et al. Acute heart failure - a call to action. Br J Cardiol
2013;20(2):S1-S11.
[4] Felker et al. Clinical trial of pharmacological therapies in acute heart
failure syndromes, Circ Heart Fail 2010;3:314-325.
[5] Novartis, data on file: approximately 1.86 million diagnosed events in the
US and 1.6 million in the top 5 EU countries.
[6] Mosterd A, Hoes A. Clinical epidemiology of heart failure. Heart
2007;93:1137-1146.
[7] Teerlink et al. Serelaxin, recombinant human relaxin-2, for treatment of
acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet
2013;381:29-39.
[8] FDA. Frequently Asked Questions: Breakthrough Therapies.
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticA
ctFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm accessed 13
August 2013.
[9] Teichman et al. Relaxin, a pleiotropic vasodilator for the treatment of
heart failure. Heart Fail Rev 2009;14:321-329.
[10] Teichman et al. Relaxin: Review of biology and potential role in treating
heart failure. Curr Heart Fail Rep 2010;7:75-82.
[11] Solomon S. PARAMOUNT: Efficacy and safety of LCZ696, a first-in-class
angiotensin receptor neprilysin inhibitor, in patients with heart failure and
preserved ejection fraction: Primary results from the PARAMOUNT study. ESC
Presentation at European Society of Cardiology, August 26, 2012.
[12] ClinicalTrials.gov: Prospective comparison of ARNI with ACEI to determine
impact on global mortality and morbidity in patients with heart failure
(PARADIGM-HF). http://clinicaltrials.gov/ct2/show/NCT01035255. Accessed August
2012.
[13] Roger et al. Heart disease and stroke statistics--2012 update : A report
from the American Heart Association. Circulation 2012;125:e2-e220.
[14] Dickstein et al. ESC Guidelines for the diagnosis and treatment of acute
and chronic heart failure 2008. Eur Heart J 2008;29:2388-2442.
[15] Forman et al. Influence of age on the management of heart failure: Findings
from Get With the Guidelines-Heart Failure (GWTG-HF). Am Heart J
2009;157:1010-1017.
[16] Healthcare Cost and Utilization Project 2009 (http://www.hcup-
us.ahrq.gov/reports/factsandfigures/2009/pdfs/FF_2009_exhibit2_4.pdf)
# # #
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Datum: 02.09.2013 - 14:01 Uhr
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