Novartis reports new Phase III data showing omalizumab significantly improves itch in patients with severe form of chronic skin disease CSU[1]
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Novartis reports new Phase III data showing omalizumab significantly improves
itch in patients with severe form of chronic skin disease CSU[1]
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* Omalizumab met all primary and secondary endpoints in pivotal GLACIAL study
of patients with refractory chronic spontaneous urticaria (CSU)[1]
* Omalizumab found to be effective, safe and well tolerated in refractory CSU
patients, including those on antihistamines at up to four times the approved
dose[1]
* By Week 12 omalizumab eliminated or suppressed symptoms in more than half of
patients who failed multiple therapies; benefit sustained during active
treatment[1]
Basel, June 26, 2013 - Novartis announced today late-breaking results showing
omalizumab met all primary and secondary endpoints of a pivotal Phase III safety
registration study in chronic spontaneous urticaria (CSU)[1], a chronic and
debilitating form of hives with limited approved treatment options[2-4]. The
data was presented for the first time at the European Academy of Allergy and
Clinical Immunology-World Allergy Organization (EAACI-WAO) World Allergy and
Asthma Congress 2013 in Milan, Italy. Omalizumab is not currently approved or
indicated for CSU. Regulatory submissions for omalizumab in CSU are on track for
later this year.
GLACIAL is the second of three pivotal Phase III studies that investigate the
efficacy and safety of omalizumab in CSU. The study results supported the
efficacy, safety and tolerability of omalizumab in patients with refractory CSU,
a chronic and debilitating skin disease with intractable itch and hives[1]. Up
to 40% of CSU patients fail on antihistamines, even those taking up to four
times the approved dose[5]. Antihistamines, at the approved dose, are currently
the only licensed treatment for CSU.
"This is encouraging news for people living with CSU, whose quality of life is
greatly impacted by this serious disease and who currently have few treatment
options," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals.
"Novartis is committed to doing all we can for these patients by working to
develop an important advance in CSU treatment, where unmet medical need remains
high."
Specifically, more than one third of omalizumab-treated patients in the GLACIAL
study were completely itch- and hive-free by Week 12, compared to 5% of placebo-
treated patients (p<0.001)[1]. During the same time period, the proportion of
patients with well controlled CSU symptoms (itch, hives) was four times higher
in the omalizumab group compared to placebo (52% and 12% respectively,
p<0.001)[1]. The significant improvements observed with omalizumab were
sustained throughout the treatment period up to Week 24[1].
The study also evaluated impact on quality of life, an important measure as up
to 80% of patients with CSU suffer negative effects on their quality of life
including sleep deprivation and psychological comorbidities such as depression
and anxiety[6]. Patients receiving omalizumab experienced nearly double the
improvement in a quality of life measure compared to placebo (reduction of 9.7
and 5.1 respectively, (p<0.001)), as assessed by improvement from baseline in
the Dermatology Life Quality Index (DLQI)[1]. This is significant, given that at
the start of the study patients in both groups had a baseline score of over 12,
indicating a severe impact on a patient's quality of life. Omalizumab reduced
the score by nearly 10 points by Week 12, lowering the DLQI score to 2.3. This
signified a marked improvement in patients' quality of life[7].
Omalizumab-treated patients also experienced a significant increase in the
proportion of days free of deep tissue swelling, also known as angioedema
(p<0.001)[1]. Angioedema is a painful and disfiguring condition experienced by
approximately 40%-50% of patients with CSU[5].
In the study, the incidence and severity of adverse events (AEs) was similar
between omalizumab and placebo recipients, with no new safety issues
identified[1]. There were no major imbalances in AEs, with the exception of
headache and upper respiratory tract infections, which were more common in the
omalizumab group; and sinus congestion, migraine and idiopathic urticaria, which
were more common in the placebo group[1].
CSU is also known as chronic idiopathic urticaria (CIU) in the US, and is a
severe and distressing skin condition characterized by red, swollen, itchy and
sometimes painful hives or wheals on the skin[2],[3] that spontaneously present
and re-occur for more than six weeks[4]. There is no approved treatment for CSU
that is broadly effective in more than 50% patients who are not responding to
approved doses of antihistamines, the mainstay of current symptomatic
therapy[6]. Medical guidelines allow for increased doses of antihistamines, up
to four times the approved dose, to increase symptom control in some
patients[6]. At any given time, the prevalence of CSU is 0.5% to 1%
worldwide[6].
Omalizumab is being jointly developed by Novartis and Genentech, Inc. for CSU.
Regulatory submissions for omalizumab in CSU are on track for later this year.
About the GLACIAL Study
GLACIAL was a 40-week, global, multi-center, randomized double-blind study that
evaluated the safety and efficacy of omalizumab compared to placebo. It involved
335 patients aged between 12 and 75 with moderate-to-severe refractory CSU
despite receiving standard-of-care therapy, consisting of concomitant H1
antihistamine therapy (up to four times the approved dose) and other background
medications including H2 antihistamines and/or leukotriene receptor antagonists
(LTRAs)[1]. Patients were randomized to omalizumab 300 mg or placebo (3:1),
given subcutaneously every four weeks for a total period of 24 weeks[1].
Omalizumab met all pre-specified primary and secondary endpoints in the
study[1]. The safety endpoints assessed AEs, serious AEs (SAEs), antibody data
and changes in vital signs/laboratory evaluations. Efficacy endpoints included
weekly itch severity, health-related quality of life, number of angioedema-free
days, weekly hive scores (number, size), reduction or elimination of disease
symptoms (itch, hives) and the time it took to achieve a clinically significant
benefit.
The key efficacy endpoint was assessed by the weekly Itch Severity Score (ISS),
on a 21-point scale. The study showed that omalizumab significantly improved the
mean weekly ISS from baseline by 8.6 (p<0.001), compared to a 4.0 improvement in
patients on placebo[1]. Disease control was also assessed by a measure of itch
and hives called the weekly urticaria activity score (UAS7), where any score of
6 or less out of a 42 point score is considered to represent a well-controlled
disease and a score of zero represents a complete resolution of symptoms.
Seven (2.8%) patients experienced SAEs in the omalizumab group, compared to
three (3.6%) in the placebo group[1]. No deaths were reported during this
study[1].
It is the first study to evaluate omalizumab as concomitant therapy beyond H1
antihistamines, also including H2 antihistamines and/or LTRAs in refractory CSU
patients. The study results supported the safety and effectiveness of omalizumab
in patients with refractory CSU.
About Omalizumab (Xolair(®))
Omalizumab is a targeted therapy unique in binding to immunoglobulin E (IgE). It
is not currently approved or indicated for CSU. Research is ongoing to
understand the mechanism of action of omalizumab in CSU, and to investigate its
impact on the drivers of CSU[5]. It may suppress histamine-induced skin
reactions through its reduction of IgE and downstream effects on cellular
activation mechanisms[8].
Omalizumab is approved for the treatment of severe allergic asthma under the
brand-name Xolair(®) in more than 90 countries, including the US since 2003 and
the EU since 2005. In the EU it is approved for the treatment of severe allergic
asthma in children (aged six and above), adolescents, and adults. Following
approval in the EU, a liquid formulation of Xolair in pre-filled syringes has
been launched in most European countries. In the US, Xolair (omalizumab) for
subcutaneous use in appropriate allergic asthma patients is co-promoted by
Novartis Pharmaceuticals Corporation and Genentech, Inc.
As an investigational compound, the safety and efficacy profile of omalizumab
has not been established in CSU. Omalizumab has been available for CSU through
carefully controlled and monitored clinical trials. These trials are designed to
better understand the potential benefits and risks of the compound. For various
reasons, including the uncertainty of clinical trials, there is no guarantee
that omalizumab will become commercially available for CSU anywhere in the
world.
About Novartis in Specialty Dermatology
Novartis is committed to developing innovative, life-changing specialty
dermatology therapies to redefine treatment paradigms and transform patient care
in severe skin diseases where there are remaining high unmet medical needs. The
Novartis specialty dermatology portfolio includes two unique targeted products
in Phase III development, omalizumab (Xolair(®)) for CSU and AIN457
(secukinumab) for moderate-to-severe plaque psoriasis. There are also more than
10 compounds in early stage development for a wide range of severe skin diseases
in the Novartis specialty dermatology portfolio.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "on track," "encouraging," "committed," "working to
develop," "ongoing," "investigational," "potential," "will," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for omalizumab, potential marketing approvals for AIN457
or any other dermatology products, or regarding potential future revenues from
omalizumab, AIN457 or such other 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 omalizumab will be
approved for any additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that AIN457 or any other
dermatology products will be submitted or approved for sale in any market, or at
any particular time. Neither can there be any guarantee that omalizumab, AIN457
or any such other products will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding omalizumab could be
affected by, among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; 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 129,000
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] Maurer M, Staubach P, Ashby M, et al. The safety and efficacy of omalizumab
in chronic idiopathic/spontaneous urticaria (CIU/CSU): results from a Phase III
randomized, double-blind, placebo-controlled study. European Academy of Allergy
and Clinical Immunology-World Allergy Organization (EAACI-WAO) World Allergy and
Asthma Congress annual meeting 2013. Late Breaking Poster. 25 June 2013, 12:00
p.m.
[2] Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria
(Hives)." http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed
November 14, 2012.
[3] American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin
Allergy Overview." http://www.aaaai.org/conditions-and-
treatments/allergies/skin-allergy.aspx. Accessed November 14, 2012.
[4] Casale T, Maurer M, Hsieh HJ, et al. Efficacy and safety of omalizumab in
chronic idiopathic/spontaneous urticaria: results from a phase III, randomized,
double-blind, placebo-controlled trial (ASTERIA II). American Academy of
Allergy, Asthma & Immunology (AAAAI) annual meeting. 4611 Late Breaking Oral
Abstract I. 25 March 2013, 2:30 pm.
[5] Sánchez-Borges M, Asero R, Ansotegui IJ, et al. Diagnosis and treatment of
urticaria and angioedema: a worldwide perspective (position paper). World
Allergy Organization Journal. 2012; 5:125-147.
[6] Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
chronic spontaneous urticaria. A GA2LEN task force report. Allergy
2011; 66: 317-330.
[7] Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AY, et. al. Translating
the science of quality of life into practice: What do dermatology life quality
index scores mean?. J Invest Dermatol. 2005 Oct;125(4):659-64.
[8] European Medicines Evaluation Agency. Omalizumab (XOLAIR). Summary of
product characteristics. Available at: www.ema.europa.eu. Accessed 7 June, 2013.
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Datum: 26.06.2013 - 07:16 Uhr
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