Novartis receives positive CHMP recommendation for Ilaris® to treat rare diseases in adults and children called Periodic Fever Syndromes
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Novartis International AG /
Novartis receives positive CHMP recommendation for Ilaris® to treat rare
diseases in adults and children called Periodic Fever Syndromes
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The issuer is solely responsible for the content of this announcement.
* Periodic Fever Syndromes are rare diseases mostly affecting children[1] and
cause recurrent and disabling fevers with potentially life-threatening
complications[2]
* Ilaris® (canakinumab) is recommended for approval in Europe for the
treatment of three Periodic Fever Syndromes: TRAPS, HIDS/MKD and FMF disease
* If approved, Ilaris will be the first and only biologic treatment in Europe
for these rare diseases, providing rapid and sustained disease control for
patients[3]
Basel, December 16, 2016 - Novartis announced today that the Committee for
Medicinal Products for Human Use (CHMP) has recommended approval of Ilaris(®
)(canakinumab) in Europe to treat three rare and distinct Periodic Fever
Syndromes.
If approved, Ilaris will be the first and only approved biologic treatment in
Europe for Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS),
Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and
Familial Mediterranean Fever (FMF).
"Few treatments exist for people with these potentially life-threatening
conditions. Today's positive recommendation is a great stride forward for
patients who urgently need new treatment options," said Paul Hudson, CEO,
Novartis Pharmaceuticals. "Novartis is committed to paving the way forward for
rare diseases especially through treatments like Ilaris which has the potential
to raise the standard of care."
The CHMP positive opinion, which also recommends the use of a new formulation
which is a 150 mg/ml solution for injection, is based on results from the
pivotal Phase III CLUSTER study. Results 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[3]. Data show Ilaris to be a well-tolerated
and effective treatment for these three rare conditions.
All three conditions are part of a group of rare autoinflammatory diseases
called Periodic Fever Syndromes, which are also referred to as Hereditary
Periodic Fevers (HPF). These can 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]. 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[1].
In August 2016, the European Commission approved Ilaris for a license extension
to treat patients with Adult-Onset Still's Disease (AOSD), a rare type of
inflammatory arthritis. The US Food and Drug Administration (FDA) previously
granted three simultaneous approvals of Ilaris for the treatment of TRAPS,
HIDS/MKD and FMF in September 2016.
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[1].
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 defences[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]. Novartis has reformulated Ilaris from a powder
that needed to be reconstituted into a solution prior to use to a solution for
injection (ready to use) which will ease administration of the product.
Ilaris is currently approved and marketed for the treatment of Systemic Juvenile
Idiopathic Arthritis (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,
US, Canada, and Japan for the treatment of Cryopyrin-Associated Periodic
Syndromes (CAPS): rare, lifelong, genetic disorders with debilitating symptoms.
In the EU, Ilaris is approved for following subtypes of CAPS: Muckle-Wells
syndrome (MWS), neonatal-onset multisystem inflammatory disease (NOMID)/chronic
infantile neurological, cutaneous, articular syndrome (CINCA), severe forms of
familial cold autoinflammatory syndrome (FCAS)/familial cold urticaria (FCU)
presenting with signs and symptoms beyond cold-induced urticarial skin rash. 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 "positive CHMP recommendation," "recommended for approval,"
"will," "recommended approval," "positive recommendation," "stride forward,"
"committed," "potential," "positive opinion," "recommends," 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.
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References
[1] 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
December 2016.
[2] Cleveland Clinic. Periodic Fever Syndrome. Available at:
https://my.clevelandclinic.org/services/orthopaedics-rheumatology/diseases-
conditions/periodic-fever-syndrome. Accessed December 2016.
[3] Novartis Data on File.
[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
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E-mail: media.relations(at)novartis.com
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 16.12.2016 - 13:27 Uhr
Sprache: Deutsch
News-ID 513457
Anzahl Zeichen: 12003
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Town:
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Kategorie:
Business News
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