-
The EC approval underscores the
long-term safety and efficacy of Xolair demonstrated in clinical
studies and by 13 years of real-world use in
Europe[1]
-
Xolair® (omalizumab)
prefilled syringe (PFS) is the first and only biologic to receive
European Commission (EC) approval for self-administration in severe
allergic asthma (SAA) and chronic spontaneous urticaria
(CSU)
-
Novartis is reimagining care in
SAA and CSU by providing patients the flexibility to fit their treatment around their
lives
Basel, December 13, 2018
- Novartis today announced that the European
Commission (EC) has approved Xolair® (omalizumab)
prefilled syringe (PFS) for self-administration, allowing patients
with severe allergic asthma (SAA) and chronic spontaneous urticaria
(CSU) to administer their own treatment. With this approval, Xolair
is the first and only biologic to offer the option of
self-administration for SAA and CSU.
Xolair, which targets immunoglobulin E (IgE), is
the first and only biologic to be approved in the European Union,
Iceland, Norway, and Liechtenstein for self-administration (or
administration by a trained caregiver) for the treatment of SAA in
patients 6 years of age and older that have difficulty in
controlling their asthma symptoms and for CSU in patients 12 years
of age and older who continue to have hives that are not controlled
by H1 antihistamines. Studies in severe allergic asthma and chronic
spontaneous urticaria have shown that appropriately trained
patients can effectively self-administer Xolair at home[1]-[3].
The efficacy of Xolair has been demonstrated in
large-scale clinical trials and real world studies. Xolair has been
shown to reduce severe exacerbations and corticosteroid use in
SAA[1], as well as rapidly reduce symptoms in CSU[4].
The EC approval will allow patients with no known
history of anaphylaxis to self-inject Xolair PFS, or be injected by
a trained lay-caregiver, from the fourth dose onwards, if a
physician determines that this is appropriate[5]. The patient or
the caregiver must have been trained in the correct sub-cutaneous
injection technique and the recognition of the early signs and
symptoms of serious allergic reactions[5].
"Today's positive news is a big step forward for
patients living with immunoglobulin E- mediated asthma and chronic
spontaneous urticaria. Decreasing the number of regular clinic
visits allows patients the flexibility to fit their treatment
around their lives and helps to reduce the burden of these
diseases. It also allows physicians a greater capacity for patients
who need extra care, which is important" said Professor Dr.
Karl-Christian Bergmann, Allergy Center Charité, Berlin.
Administered via injection every two or four
weeks, Xolair is widely used and well tolerated[6]. With 13 years
of physician experience in Europe and one million patient years of
exposure, use of Xolair in SAA and CSU is supported by a wealth of
evidence from randomized clinical trials and real-world
studies[1]-[3]. Anaphylactic reactions were rare in clinical trials
(>= 1/10,000 to < 1/1,000)[5] and via post-marketing reports
(approximately 0.2 percent)[5].
About Allergic Asthma and Chronic
Spontaneous Urticaria
Asthma is a serious and chronic lung disease affecting an estimated
235 million people around the world[7]. It causes swelling and
narrowing of the airways, making breathing difficult[7]. Allergic
asthma, the most common form of asthma, accounts for approximately
60 percent of asthma cases[8],[9].
Urticaria is a severe disease characterized by
persistent hives and/or painful deeper swelling of the skin tissue
(angioedema). When this persists for 6 weeks or more, it is
classified as chronic urticaria[10]. Chronic spontaneous urticaria
(CSU), also called chronic idiopathic urticaria (CIU), is
identified as the appearance of hives and/or angioedema without an
identifiable trigger for more than 6 weeks[10]. Most patients with
CSU remain symptomatic for more than one year, but in some
patients, symptoms may persist for decades[10].
About Xolair
Xolair (omalizumab) is the only approved antibody designed to
target and block immunoglobulin E (IgE). By reducing free IgE,
down-regulating high-affinity IgE receptors and limiting mast cell
degranulation, Xolair minimizes the release of mediators throughout
the allergic inflammatory cascade.
As an injectable prescription medicine, 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. 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 has over one million patient years of
exposure. In addition, a liquid formulation of Xolair in pre-filled
syringes has been approved in the EU and more than 10 countries
outside of the EU, including Canada, the US, and Australia. In the
US, Novartis and Genentech, Inc. work together to develop and
co-promote Xolair. Outside the US, Novartis markets Xolair and
records all sales and related costs.
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 labelling 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; global trends toward health care
cost containment, including government, payor and general public
pricing and reimbursement pressures; our ability to obtain or
maintain proprietary intellectual property protection; the
particular prescribing preferences of physicians and patients;
general political and economic conditions; safety, quality or
manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology
systems, 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 is reimagining medicine to improve and extend people's
lives. As a leading global medicines company, we use innovative
science and digital technologies to create transformative
treatments in areas of great medical need. In our quest to find new
medicines, we consistently rank among the world's top companies
investing in research and development. Novartis products reach
nearly 1 billion people globally and we are finding innovative ways
to expand access to our latest treatments. About 125 000 people of
more than 140 nationalities work at Novartis around the world. Find
out more at www.novartis.com.
Novartis is on Twitter. Sign up to follow
@Novartis at http://twitter.com/novartis
For Novartis multimedia content, please visit
www.novartis.com/news/media-library
For questions about the site or required registration, please
contact media.relations@novartis.com
References
[1] Liebhaber
M and Dyer Z. J Asthma 2007; 44(3): 195-196.
[2] Ghazanfar
M and Thomsen S. J Dermatolog Treat 2018; 29(2): 196.
[3] Denman S
et al. Br J Dermatol 2016; 175(6): 1405-1407.
[4] Maurer M
et al. N Engl J Med 2013; 368(10): 924-935.
[5]
Xolair® Summary of
Product Characteristics. Novartis Europharm Limited. Available at:
INSERT WHEN AVAILABLE. Last accessed: November 2018.
[6] Humbert M
et al. Allergy 2005; 60(3): 309-316.
[7] World
Health Organization. Asthma. Available at:
http://www.who.int/respiratory/asthma/en/. Last Accessed: November
2018.
[8] American
Academy of Allergy, Asthma & Immunology (AAAAI). Allergic
Asthma Definition. Available at:
http://www.aaaai.org/conditions-and-treatments/conditions-a-to-z-search/allergic-asthma.aspx.
Accessed November 2018.
[9] Arbes S.
et al. Asthma cases attributable to atopy: Results from the Third
National Health and Nutrition Examination Survey. J Allergy Clin
Immunol 2007; 120(5): 1139-45.
[10] Maurer M, Weller K,
Bindslev-Jensen C, et al. Unmet clinical needs in chronic
spontaneous urticaria. A GA2LEN task force report. Allergy. 2011; 66(3): 317-330.
# # #
Novartis Media
Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com
Eric
Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com |
Beyza
Oezel
Global Head, Respiratory Communications
+41 61 696 9503 (direct)
+41 79 720 4038 (mobile)
beyza.oezel@novartis.com |
Novartis Investor
Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central |
|
North
America |
|
Samir
Shah |
+41 61
324 7944 |
Richard
Pulik |
+1 212
830 2448 |
Pierre-Michel Bringer |
+41 61
324 1065 |
Cory
Twining |
+1 212
830 2417 |
Thomas
Hungerbuehler |
+41 61
324 8425 |
|
|
Isabella
Zinck |
+41 61
324 7188 |
|
|
Media release (PDF)