Novartis drug Ilaris® approved by FDA to treat active systemic juvenile idiopathic arthritis, a serious form of childhood arthritis
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Novartis drug Ilaris® approved by FDA to treat active systemic juvenile
idiopathic arthritis, a serious form of childhood arthritis
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* Ilaris® (canakinumab) is the first interleukin-1 beta inhibitor for the
treatment of SJIA and the only treatment approved specifically for SJIA that
is given as a monthly subcutaneous injection[1]
* In Phase III studies, 84% of Ilaris-treated SJIA patients achieved
significant improvement of systemic and arthritic symptoms (pediatric ACR30)
after a single subcutaneous dose[1]
* SJIA is a rare, disabling autoinflammatory disease with limited treatment
options[2]; Ilaris is being investigated in other inflammatory conditions,
including several rare diseases for which approved treatment options do not
exist
Basel, May 10, 2013 - Novartis announced today that the US Food and Drug
Administration (FDA) has approved Ilaris(®) (canakinumab) for the treatment of
active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years
and older. Ilaris is the first interleukin-1 beta (IL-1 beta) inhibitor approved
for SJIA and the only treatment approved specifically for SJIA that is given as
a once-monthly subcutaneous injection[1]. SJIA is a rare and disabling form of
childhood arthritis characterized by spiking fever, rash and arthritis that can
affect children as young as 2 years old and can continue into adulthood[2],[3].
This approval was based on two Phase III trials in SJIA patients, aged 2-19,
showing significant improvement in the majority of Ilaris-treated patients[1].
Study 1 showed that 84% of patients treated with one subcutaneous dose of Ilaris
achieved the primary endpoint of the adapted pediatric American College of
Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for placebo at Day
15[1]. In the open-label part of Study 2, 92 of 128 patients attempted
"corticosteroid tapering". Of those 92 patients, 62% were able to substantially
reduce their use of corticosteroids, and 46% completely discontinued
corticosteroids[1]. In the controlled portion of Study 2, there was a 64%
relative reduction in the risk of flare for patients in the Ilaris group as
compared to those in the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to
0.75).
"In the US, this approval marks the second Ilaris indication for patients living
with rare, autoinflammatory conditions," said Timothy Wright, MD, Global Head of
Development, Novartis Pharmaceuticals. "We are committed to studying Ilaris in
other IL-1 beta mediated inflammatory diseases, including several rare diseases
for which treatment options do not currently exist."
SJIA affects 5-15 children per 100,000 in the United States,and is the most
severe subtype of juvenile idiopathic arthritis[3]-[5]. Although the disease can
be life-threatening, treatment options are limited. Corticosteroids are often
used to treat symptoms and pain despite their long term use being associated
with potentially serious adverse effects, including Cushing syndrome, growth
suppression and osteoporosis[1],[6],[7].
Ilaris is being investigated in a number of rare autoinflammatory conditions,
including Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS),
colchicine-resistant Familial Mediterranean Fever (FMF) and Hyper IgD Syndrome
(HIDS). Ilaris is considered an investigational agent for these conditions at
this point in time. As such, the role that Ilaris could play in treating these
conditions and potential benefit to patients is still being determined.
About the Pivotal Phase III Studies
Study 1, a 4-week, randomized, double-blind, placebo-controlled study, involved
84 patients between the ages of 2 and 19 years with active SJIA[1],[2]. Patients
were treated with either a single subcutaneous dose of Ilaris (4 mg/kg, up to
300 mg) (n=43) or placebo (n=41)[1]. The primary endpoint was the proportion of
patients achieving the adapted pediatric American College of Rheumatology (ACR)
30 response criteria and resolution of fever from baseline at Day 15[1]. This
means that patients had at least a 30% improvement in systemic and arthritic
symptoms versus baseline. The study met its primary endpoint.
Study 2, a two-part study, had an open-label, single-arm active treatment in
Part I followed by a randomized, double-blind, placebo-controlled, event-driven
withdrawal design in Part II[1]. A total of 177 patients between the ages of 2
and 19 years with active SJIA were enrolled in the study[1]. Some of these
patients had previously participated in the Study 1. In Part I, patients
received a subcutaneous dose of Ilaris (4 mg/kg, up to 300 mg) every 4 weeks[1].
The primary endpoint of Part I was to assess whether treatment with Ilaris
allowed successful tapering of corticosteroids in at least 25% of SJIA patients
who entered the study using a corticosteroid.
In Part II of the study, patients were randomized to either continue receiving
Ilaris, or to receive placebo every 4 weeks ("placebo-after-Ilaris group"),
until a pre-specified number (37) of flare-events ("flares") had occurred[1].
The primary endpoint of Part II was to demonstrate that the time to flare was
longer with Ilaris than with placebo.
The primary endpoints for Study 1 and Study 2 were all met.
About Ilaris
Ilaris is a selective, fully human, monoclonal antibody that inhibits IL-1 beta,
which is an important part of the body's immune system defenses[1]. Excessive
production of IL-1 beta plays a prominent role in certain inflammatory
diseases[8]. Ilaris works by neutralizing IL-1 beta for a sustained period of
time, therefore inhibiting inflammation[1].
In addition to its approval for SJIA in the US, Ilaris is approved in the EU for
the treatment of refractory gouty arthritis, and in more than 60 countries,
including in the EU, US, Switzerland and Japan for the treatment of Cryopyrin-
Associated Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with
debilitating symptoms[1]. The approved indication may vary depending upon the
individual country.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "is being studied," "committed," "is being investigated,"
"investigational" "potential," "could," or similar expressions, 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 reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results
with Ilaris to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that Ilaris will be submitted or approved for any additional indications or
labeling in any market. Nor can there be any guarantee that Ilaris will achieve
any particular levels of revenue in the future. In particular, management's
expectations regarding Ilaris could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; government, industry
and general public pricing pressures; competition in general; the company's
ability to obtain or maintain patent or other proprietary intellectual property
protection; unexpected manufacturing issues; the impact that the foregoing
factors could have on the values attributed to the Novartis Group's assets and
liabilities as recorded in the Group's consolidated balance sheet, and other
risks and factors referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those anticipated, believed, estimated
or expected. 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, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 129,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
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References:
1. Ilaris [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals
Corp; 2013.
2. Woo P. Systemic juvenile idiopathic arthritis: diagnosis, management, and
outcome. Nat Clin Pract Rheumatol 2006; 2(1):28-34.
3. Ramanan AV, Grom AA. Does systemic-onset juvenile idiopathic arthritis
belong under juvenile idiopathic arthritis? Rheumatology (Oxford)
2005; 44(11):1350-3.
4. Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of
Rheumatology Recommendations for the Treatment of Juvenile Idiopathic
Arthritis: Initiation and Safety Monitoring of Therapeutic Agents for the
Treatment of Arthritis and Systemic Features. Arthritis Care & Research
2011; 63(4):465-482.
5. Dewitt EM, Kimura Y, Beukelman T, et al. Consensus Treatment Plans for New-
Onset Systemic Juvenile Idiopathic Arthritis. Arthritis Care & Research
2012; 64(7):1001-1010.
6. U.S. National Library of Medicine (NLM), National Institutes of Health
(NIH). Cushing Syndrome. Available at:
http://www.nlm.nih.gov/medlineplus/ency/article/000389.htm. Last accessed:
12/12/12.
7. Teitelbaum SL,Seton MP, Saag KG. Should Bisphosphonates be Used for Long-
Term Treatment of Glucocorticoid-Induced Osteoporosis? Arthritis Rheum.
2011 February 63(2): 325-328. doi:10.1002/art.30135.
8. Martinon F, Petrilli V. Gout-associated uric acid crystals activate the
NALP3 inflammasome. Nature 2006; 440(9): 237-241.
# # #
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Datum: 10.05.2013 - 07:15 Uhr
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