-
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 26th 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 H1-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 delays or
government regulation generally; our ability to obtain or maintain
proprietary intellectual property protection; the particular
prescribing preferences of physicians and patients; global trends
toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures; general
economic and industry conditions, including the effects of the
persistently weak economic and financial environment in many
countries; safety, quality or 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, 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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