Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption
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Novartis International AG /
Novartis' Xolair® confirms re-treatment efficacy in chronic spontaneous
urticaria patients after treatment interruption
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* OPTIMA Phase IIIb data re-confirm that almost two thirds of patients treated
with Xolair 300 mg for 6 months are well-controlled[1]
* Should a treatment pause be necessary, data showed almost 90% of chronic
spontaneous urticaria (CSU) patients - previously well controlled - regained
effective symptom control within 12 weeks of re-treatment on Xolair[2]
* Previous studies have shown that inadequately controlled CSU has a major
impact on sleep, social lives and work[3]
The digital press release with multimedia content can be accessed here:
Basel, September 16, 2017 - Novartis, a global leader in Immunology &
Dermatology, announced today new data showing almost 90% of chronic spontaneous
urticaria (CSU) patients who responded well to initial Xolair(®) (omalizumab)
treatment regained symptom control within 12 weeks of Xolair retreatment
following a treatment interruption, based on Weekly Urticaria Activity Score
(UAS7) criteria (UAS7=<6)[2]. Findings were presented at the 26(th) European
Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland.
CSU is a distressing skin condition that appears spontaneously and causes
persistent hives and/or painful deeper swelling of the skin for 6 weeks or
more[4]. International treatment guidelines state that the goal of treatment for
CSU is the complete elimination of symptoms[5],[6]. For CSU patients who have
not successfully controlled their symptoms with H1 antihistamine (H1-
antagonists) treatment, Xolair can reduce or eliminate symptoms[4],[7],[8].
Xolair is the first and only approved therapy for CSU patients who show an
inadequate response to H1 antihistamines.
"CSU can have a severe impact on quality of life. Its unpredictable nature,
combined with the fact that some physicians mistakenly dismiss it as a trivial
condition, can mean patients do not get adequate treatment with effective and
long-term symptoms control," said Vas Narasimhan, Global Head, Drug Development
and Chief Medical Officer, Novartis. "If for some reason treatment has been
interrupted, these data give patients and physicians confidence that it's
possible to regain effective symptom control with Xolair."
In the OPTIMA study, 314 participants with symptoms of CSU despite taking H1
antihistamines were randomized to 24 weeks of treatment with either Xolair 150
mg or 300 mg. Individuals who responded well to this initial treatment (UAS7=<6)
underwent a pause in treatment and then, if symptoms returned (UAS7>16), were
retreated[2]. Symptom control (UAS7=<6) was achieved in almost 90% of retreated
patients within three months[2]. Xolair was well-tolerated at both doses and
during both dosing periods[2].
Further data from OPTIMA showed that, after 24 weeks of treatment, 65% of
participants treated monthly with Xolair 300 mg were well-controlled (UAS7=<6)
compared to 15% treated with 150 mg[2]. Between 8 and 24 weeks of treatment,
79% of patients starting on Xolair 150 mg were not well-controlled (UAS7>6) and
had their dose increased to 300 mg[1]. After 3 additional doses (300 mg), 45% of
these patients achieved symptom control - indicating the importance of up-dosing
in some patients[1].
About chronic urticaria and CSU
Chronic urticaria (CU) is a severe disease that is characterized by the
reoccurrence of persistent hives and/or sometimes painful deeper swelling of the
skin for 6 weeks or more[4]. At any given time, the prevalence of CU is up to
1% of the world's population, and up to two thirds of these patients have CSU[6]
- a form of the condition that can occur unpredictably without an identifiable
trigger[6],[9]. Patients with CU remain symptomatic on average for about 5
years, but in some patients, symptoms may persist for decades[10].
Although CU has a significant impact on patients' quality of life, research has
highlighted that some physicians disregard the disease as a trivial
condition[10],[11].
About OPTIMA
OPTIMA is a Phase IIIb, international, multicenter, randomized, open-label, non-
comparator study. A total of 314 patients with CSU experiencing symptoms despite
treatment with H(1)-antagonists were initially randomized 4:3 to Xolair 150 or
300 mg for 24 weeks in the first dosing period. Based on UAS7, patients then
entered one of the following phases: step-up to 300 mg (if treated initially
with 150 mg and UAS7>6 at any visit between week 8-24), or withdrawal period (if
UAS7=<6), or continued treatment for 12 weeks (if treated initially with 300 mg
and UAS7>6 at week 24).
About Xolair
Xolair is a targeted therapy that binds to immunoglobulin E (IgE). In allergic
diseases and asthma, the binding of IgE by Xolair reduces symptoms by
suppressing multiple cell activation mechanisms, including some that result in
histamine release. Research is ongoing to understand the mechanism of action of
Xolair in CSU, which could lead to a deeper understanding of how the disease
develops.
Xolair is approved for the treatment of CSU in over 80 countries including the
European Union and for chronic idiopathic urticaria (CIU) as it is known in the
US and Canada. Xolair is approved for the treatment of moderate-to-severe or
severe persistent allergic asthma in more than 90 countries, including the US
since 2003 and the EU since 2005 and has over 800,000 patient years of exposure.
In addition, a liquid formulation of Xolair in pre-filled syringes has been
approved in the EU and 10 countries outside of the EU, including Canada and
Australia. In the US, Novartis Pharmaceuticals Corporation and Genentech, Inc.
work together to develop and co-promote Xolair.
About Novartis Immunology & Dermatology
Novartis is a global leader in Immunology & Dermatology. We are transforming the
lives of people living with immunologic diseases, focusing on specialty
dermatology, rheumatology, auto-inflammatory, transplant and specialty liver
diseases where high unmet medical needs exist. Our leading brand Cosentyx(®)
(secukinumab) is an innovative biologic approved in more than 70 markets for the
treatment of moderate-to-severe psoriasis (PsO), ankylosing spondylitis (AS) and
psoriatic arthritis (PsA). Other key brands include Xolair(®) (omalizumab)* in
chronic spontaneous urticaria (CSU), Zortress(®)/Certican(®) and Myfortic(®) in
transplant and Ilaris(®) (canakinumab), approved to treat several rare diseases
including some Periodic Fever Syndromes. Our I&D pipeline includes multiple
compounds in liver disease.
*In the US, Novartis Pharmaceuticals Corporation and Genentech, Inc. work
together to develop and co-promote Xolair.
Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in this press
release, or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations 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 the
investigational or approved products described in this press release will be
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that such
products will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among other things,
the uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; regulatory actions or
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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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
119,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Gulliver W et al. Omalizumab Dose Step-Up and Treatment Response in Patients
With Chronic Idiopathic Urticaria / Chronic Spontaneous Urticaria: Results from
the OPTIMA Study. Poster presented at the 26th Congress of the European Academy
of Dermatology and Venereology (EADV), 13-17 September 2017.
[2] Lynde C et al. Omalizumab Retreatment of Patients With Chronic Idiopathic
Urticaria / Chronic Spontaneous Urticaria Following Return of Symptoms: Primary
Results of the OPTIMA Study. Presented at the 26th Congress of the European
Academy of Dermatology and Venereology (EADV), 13-17 September 2017.
[3] Maurer M et al. The burden of chronic spontaneous urticaria is substantial:
Real-world evidence from ASSURE-CSU. Allergy 2017. Advanced online publication.
DOI:10.1111/all.13209
[4] Saini S, Bindslev-Jensen C, Maurer M et al. Efficacy and Safety of
Omalizumab in Patients with Chronic Idiopathic/Spontaneous Urticaria Who Remain
Symptomatic on H1 Antihistamines: A Randomized, Placebo-Controlled Study. J
Investigative Dermatology 2014;135:67-75
[5] Zuberbier T et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition,
classification, diagnosis, and management of urticaria: the 2013 revision and
update. Allergy 2014; 69(7):e1-29.
[6] Maurer M et al. Unmet clinical needs in chronic spontaneous urticaria. A
GA2LEN task force report. Allergy 2011; 66: 317-330.
[7] Maurer M, Rosén K, Hsieh HJ et al. Omalizumab for the treatment of chronic
idiopathic or spontaneous urticaria. NEJM. 2013; 368(10):924-35.
[8] Kaplan A, Ledford D, Ashby M et al. Omalizumab in patients with symptomatic
chronic idiopathic/spontaneous urticaria despite standard combination therapy. J
Allergy Clin Immunol. 2013 Jul;132(1):101-9.
[9] British Association of Dermatologists. Urticaria and angioedema. Available
online at: http://www.bad.org.uk/shared/get-file.ashx?id=184&itemtype=document.
Last accessed June 2017.
[10] Sánchez-Borges M et al. Diagnosis and Treatment of Urticaria and
Angioedema: A Worldwide Perspective. WAO Journal 2012; 5: 125-147.
[11] O'Donnell BF et al. The impact of chronic urticaria on the quality of life.
British Journal of Dermatology 1997; 136: 197-201.
# # #
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.09.2017 - 16:00 Uhr
Sprache: Deutsch
News-ID 560143
Anzahl Zeichen: 15477
contact information:
Town:
Basel
Kategorie:
Business News
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