Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions
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Novartis International AG /
Novartis receives three new FDA approvals for the expanded use of Ilaris
treating rare Periodic Fever Syndrome conditions
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* Ilaris(®) (canakinumab) is the first and only US FDA-approved biologic
treatment for patients with TRAPS, HIDS/MKD and FMF disease
* These three simultaneous approvals conducted under FDA Priority Review
follow Breakthrough Therapy Designations to address the unmet need of
patients
* Ilaris provides rapid, sustained and complete disease control for patients
with these rare and debilitating Periodic Fever Syndromes
The digital press release with multimedia content can be accessed here:
Basel, September 23, 2016 - Novartis announced today that the US Food and Drug
Administration (FDA) has granted three simultaneous approvals for the expanded
use of Ilaris(® )(canakinumab) to treat three rare and distinct types of
Periodic Fever Syndromes.
Ilaris is the first and only FDA approved biologic treatment for Tumor Necrosis
Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D
Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean
Fever (FMF). All three conditions are part of a group of rare autoinflammatory
diseases called Periodic Fever Syndromes[2], which are also referred to as
Hereditary Periodic Fevers (HPF). The most common syndrome is FMF, which mainly
affects people of Eastern Mediterranean ancestry. It affects 1 in 250 to 1 in
1,000 individuals in these populations, many of whom are children[3].
"Gaining three simultaneous FDA approvals of Ilaris is a momentous turning point
for people who suffer with these severe, debilitating diseases," said Paul
Hudson, CEO, Novartis Pharmaceuticals. "There is a significant unmet need in
these conditions, particularly in children, and Novartis is proud to provide a
new treatment option to those who so desperately need it."
The FDA approvals are based on results from the pivotal Phase III CLUSTER study
which showed rapid (at Day 15) and sustained disease control with Ilaris
compared to placebo through 16 weeks, in patients with either TRAPS, HIDS/MKD or
FMF[1]. As a result of the superior data, the FDA granted Ilaris Breakthrough
Therapy status and priority reviews for each of the three Periodic Fever
Syndrome conditions.
Periodic Fever Syndromes are a group of rare autoinflammatory diseases that
cause disabling and persistent fevers which may be accompanied by joint pain,
swelling, muscle pain and skin rashes with complications that can be life-
threatening[2]. Ilaris is already approved and marketed in the US as an
effective and well-tolerated treatment for another Periodic Fever Syndrome
condition - Cryopyrin-Associated Periodic Syndromes (CAPS), and another
autoinflammatory condition - Systemic Juvenile Idiopathic Arthritis (SJIA). In
August 2016, the European Commission approved Ilaris for a license extension to
also treat patients with Adult-Onset Still's Disease (AOSD).
About Periodic Fever Syndromes
Periodic Fever Syndromes are a group of diseases that cause serious recurrent
fever and pathogenic inflammation through non-infectious activation of the
immune system. Most patients present with symptoms in infancy or childhood, but
in some patients the condition only becomes apparent or diagnosed in
adulthood[2],[3].
Previous treatments for these rare conditions consisted of oral anti-
inflammatory drugs, such as corticosteroids, which were used only to help manage
the symptoms. While other medicines, such as non-steroidal anti-inflammatory
drugs, have also been used to help reduce symptoms, they do not prevent or
change the overall course of a flare[2].
About Ilaris
Ilaris is a selective, high-affinity, human monoclonal antibody that inhibits
Interleukin-1 (IL-1) beta, which is an important part of the body's immune
system defenses[4]. Excessive production of IL-1 beta plays a prominent role in
certain inflammatory diseases[5],[6]. Ilaris works by blocking the action of IL-
1 beta for a sustained period of time, therefore inhibiting inflammation that is
caused by its over-production[4].
Ilaris is currently approved and marketed for the treatment of SJIA in the US
and EU and for the treatment of AOSD and the symptomatic treatment of refractory
acute gouty arthritis in the EU. Ilaris is also approved in more than 70
countries, including in the EU, Switzerland, Canada, and Japan for the treatment
of the Periodic Fever Syndrome CAPS: rare, lifelong, genetic disorders with
debilitating symptoms. In the US, Ilaris is approved for two subtypes of CAPS:
Muckle-Wells Syndrome (MWS) and Familial Cold Autoinflammatory Syndrome (FCAS).
The approved indications may vary depending upon the individual country.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "Breakthrough Therapy Designations," "Breakthrough Therapy," or
similar terms, or by express or implied discussions regarding potential new
indications or labeling for Ilaris, or regarding potential future revenues from
Ilaris. You should not place undue reliance on these statements. Such forward-
looking statements are based on the current beliefs and expectations of
management 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 Ilaris will be submitted or approved
for any additional indications or labeling in any market, or at any particular
time. Nor can there be any guarantee that Ilaris will be commercially successful
in the future. In particular, management's expectations regarding Ilaris could
be affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected 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,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)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(at)novartis.com
References
[1] Novartis Data on File.
[2] Cleveland Clinic. Periodic Fever Syndrome. Available at:
https://my.clevelandclinic.org/services/orthopaedics-rheumatology/diseases-
conditions/periodic-fever-syndrome. Accessed September 2016.
[3] National Amyloidosis Centre. Amyloidosis Patient Information Site:
The inherited periodic fever syndromes - general information. Available at:
www.amyloidosis.org.uk/fever-syndromes/inherited-fever-syndromes/. Accessed
September 2016.
[4] Dhimolea E. Canakinumab, MAbs. 2010 Jan-Feb;2(1):3-13.
[5] Jesus AA, Goldbach-Mansky R. IL-1 blockade in autoinflammatory
syndromes. Annu Rev Med. 2014;65:223-244.
[6] Toker O, Hashkes PJ. Critical appraisal of canakinumab in the
treatment of adults and children with cryopyrin-associated periodic syndrome
(CAPS). Biologics. 2010;4:131-138.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Bhavin Vaid
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 8175 (direct)
+41 79 593 4202 (mobile) +41 79 792 7510 (mobile)
eric.althoff(at)novartis.com bhavin.vaid(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2044202/763320.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.09.2016 - 17:51 Uhr
Sprache: Deutsch
News-ID 496690
Anzahl Zeichen: 11321
contact information:
Town:
Basel
Kategorie:
Business News
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