2013-03-01 07:18:23 -
Novartis International AG /
Novartis receives EU approval for Ilaris® in patients suffering acute gouty
arthritis attacks who cannot gain relief from current treatments
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* Ilaris(®) is the first biologic approved in the EU for symptomatic pain
relief in a gouty arthritis indication, and is administered in a single,
subcutaneous injection[1]
* The intense inflammatory response associated with gouty arthritis attacks
can cause severe pain and debilitating symptoms that can last a week or
more[2] -[4]
* Existing treatments are unsuitable to treat these crippling attacks for
certain groups of gouty arthritis patients, particularly those with serious
comorbidities[5],[6]
* Ilaris, the only approved fully human monoclonal antibody targeting
interleukin-1 beta (IL-1 beta), is being investigated in a number of rare
inflammatory conditions
Basel, March 1, 2013 - Novartis announced today that the European Commission
(EC) has approved llaris (canakinumab, ACZ885) in the treatment of patients with
acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or
should not be managed with current treatment options. Ilaris is the first
biologic approved in the EU for symptomatic pain relief in a gouty arthritis
indication, and is administered in a single, subcutaneous injection of 150
mg[1].
Ilaris is specifically indicated for the 'symptomatic treatment of adult
patients with frequent gouty arthritis attacks (at least 3 attacks in the
previous 12 months) in whom non-steroidal anti-inflammatory drugs (NSAIDs) and
colchicine are contraindicated, are not tolerated, or do not provide an adequate
response, and in whom repeated courses of corticosteroids are not
appropriate'[1].
The EC also granted an additional year of data exclusivity to Novartis based on
the significant clinical benefit over existing treatments demonstrated for
Ilaris.
"The approval of Ilaris for acute gouty arthritis attacks in patients without
appropriate treatment options provides new hope for those debilitated by this
excruciating condition," said David Epstein, Division Head of Novartis
Pharmaceuticals. "Ilaris targets interleukin-1 beta, a key player in gouty
arthritis inflammation. Our vision is to realize the potential of Ilaris
wherever IL-1 beta plays a key role and available treatment options don't give
patients the help they need."
Gouty arthritis, commonly referred to as gout, is a serious, chronic and
progressive inflammatory disease that generally affects 1 to 4% of
adults[2],[7]-[10]. Gouty arthritis attacks occur when the body has a strong
inflammatory response to uric acid crystals forming in the affected joint,
typically of the toe, foot, ankle, or knee[2],[4]. The disease is associated
with a high prevalence of comorbidities, such as hypertension, kidney disease,
diabetes, dyslipidemia and cardiovascular disease. These conditions can lead to
contraindications for existing therapies and complications for disease
management[5],[6],[11],[12].
Data from two Phase III trials and their extensions, which supported the EU
approval for Ilaris in acute gouty arthritis attacks, showed that patients
treated with Ilaris experienced significantly greater pain relief compared to
the injectable steroid triamcinolone acetonide (TA)[13]. The majority of adverse
events (AEs) were mild to moderate, with infections (e.g. upper respiratory
tract infections and nasopharyngitis) being the most frequent of them.
About Ilaris Phase III Studies
Ilaris has been assessed for the treatment of acute gouty arthritis attacks in
two multicentre, randomized, double-blind, active-controlled studies in patients
with frequent gouty arthritis attacks (>=3 in the previous year) who were unable
to use NSAIDs or colchicine (due to contraindication, intolerance or lack of
efficacy). The studies were 12 weeks in duration followed by 12 week double-
blind initial extensions[13].
A total of 454 patients were randomized to receive a single dose of Ilaris 150
mg via subcutaneous injection or TA 40 mg via intramuscular injection[13].
Both trials used an internationally recognized pain scale (visual analogue
scale, or VAS) to measure differences in pain 72 hours after treatment. Pain
intensity in the overall study population was statistically significantly lower
for Ilaris 150 mg compared to TA at 72 hours (-10.7 mm, p<0.0001), with an
absolute mean decrease in VAS score of approximately -50 mm. Reduction in pain
was observed as early as 6 hours after dosing in both groups. A statistically
significant difference between treatments was observed from 24 hours to 7 days.
Ilaris also reduced the risk of subsequent attacks[13].
Safety results showed an increased incidence of AEs for Ilaris compared to TA,
with 66% vs. 53% of patients reporting any adverse event and 20% vs. 10% of
patients reporting an infection adverse event over 24 weeks[1].
A sub-analysis of these studies included 101 patients unable to use NSAIDs and
colchicine, and on stable urate lowering therapy (ULT) or unable to use ULT.
Pain relief was similar to that shown in the total study population (-10.2 mm
for Ilaris 150 mg compared with TA at 72 hours, p=0.0208)[14].
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.
Ilaris works by neutralizing IL-1 beta for a sustained period of time, therefore
inhibiting inflammation.
In addition to its approval in refractory gouty arthritis in the EU, Ilaris is
approved in more than 60 countries, including in the EU, US, Switzerland and
Japan for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). CAPS
is a suite of rare, life-long, genetic, autoinflammatory diseases with
debilitating symptoms[1]. The approved indication may vary depending upon the
individual country.
Ilaris is being investigated in a number of rare inflammatory conditions, which
include, systemic juvenile idiopathic arthritis (SJIA), Tumor Necrosis Factor
Receptor-Associated Periodic Syndrome (TRAPS), colchicine-resistant Familial
Mediterranean Fever (FMF) and cardiovascular disease. Not all patients with
these diseases would be eligible for treatment with Ilaris, if approved for the
applicable disease.
In the US, Novartis continues to work with the Food and Drug Administration
(FDA) to determine the next steps for ACZ885 in gouty arthritis, following a
Complete Response letter received in August 2011 with a request by the Agency
for additional clinical data to evaluate the benefit risk profile in refractory
patients.
About Gouty Arthritis
Gouty arthritis is the most common form of inflammatory arthritis in
adults[10],[15]. This chronic and progressive disease is characterized by
recurrent attacks in select joints[2]. The intense inflammatory response
associated with these attacks may cause severe pain and debilitating symptoms
that can last a week or more[2]-[4].
Treatments currently available to manage the pain and inflammation of gouty
arthritis attacks, such as NSAIDs, colchicine or corticosteroids, may be
inadequate or inappropriate in patients who have certain coexisting medical
problems[1],[6],[16]. As a result, there is a significant unmet medical need
among individuals with gouty arthritis.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "is being investigated," "vision,"
"hope," "potential,"
"would be," 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 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; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general; 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 128,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit
www.novartis.com.
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References
[1] Ilaris [prescribing information]. Surrey, UK: Novartis Pharmaceuticals UK
Ltd; 2013.
[2] Schumacher HR, Jr. The pathogenesis of gout. Cleve Clin J Med 2008; 75 Suppl
5:S2-4.
[3] So A, De Meulemeester M, Pikhlak A, et al. Canakinumab for the treatment of
acute flares in difficult-to-treat gouty arthritis: Results of a multicenter,
phase II, dose-ranging study. Arthritis Rheum 2010; 62(10):3064-76.
[4] Mandell BF. Clinical manifestations of hyperuricemia and gout. Cleve Clin J
Med 2008; 75 Suppl 5:S5-8.
[5] Harrold LR, Yood RA, Mikuls TR, et al. Sex differences in gout epidemiology:
evaluation and treatment. Ann Rheum Dis 2006; 65(10):1368-72.
[6] Riedel AA, Nelson M, Wallace K, Joseph-Ridge N, Cleary M, Fam AG. Prevalence
of Comorbid Conditions and Prescription Medication Use Among Patients With Gout
and Hyperuricemia in a Managed Care Setting. J Clin Rheumatol
2004; 10(6):308-14.
[7] Badley E, DesMeules M. Arthritis in Canada: an ongoing challenge. Ottawa:
Public Health Agency of Canada. 2003.
[8] Begg S, Vos T, Barker B, Stevenson C, Stanley L, Lopez AD, 2007. The burden
of disease and injury in Australia 2003. PHE 82. Canberra: AIHW.
[9] Annemans l, Spaepen E, Gaskin M, et al. Gout in the UK and Germany:
prevalence, comorbidities and management in general practice 2000-2005. Ann
Rheum Dis. 2008; 67(7):960-6.
[10] Zhu Y, Pandya B, Choi H. Increasing gout prevalence in the US over the last
two decades: The National Health and Nutrition Examination Survey (NHANES).
Presented at: The American College of Rheumatology Annual Scientific Meeting,
Oct, 2010, Atlanta, GA, USA.
[11] Choi HK, Ford ES, Li C, Curhan G. Prevalence of the metabolic syndrome in
patients with gout: the Third National Health and Nutrition Examination Survey.
Arthritis Rheum 2007; 57(1):109-15.
[12] Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy
and safety of febuxostat in the treatment of the hyperuricemia of gout: the
CONFIRMS trial. Arthritis Res Ther 2010; 12(2):R63.
[13] Schlesinger N, Alten RE, Bardin T, et al. Canakinumab for acute gouty
arthritis in patients with limited treatment options: results from two
randomised, multicentre, active-controlled, double-blind trials and their
initial extensions. Ann Rheum Dis 2012; 71(11):1839-48.
[14] Bardin T, So A, Alten R, et al. Efficacy and safety of canakinumab vs
triamcinolone acetonide in patients with gouty arthritis unable to use
nonsteroidal anti-inflammatory drugs and colchicine, and on stable urate
lowering therapy (ULT) or unable to use ULT. Abstract at: ACR/ARHP Annual
Meeting; November, 2012, Washington, D.C., USA.
[15] Silman AJ, Pearson JE. Epidemiology and genetics of rheumatoid arthritis.
Arthritis Res. 2002;4 Suppl 3:S265-72.
[16] Jordan KM, Cameron JS, Snaith M, et al. British Society for Rheumatology
and British Health Professionals in Rheumatology guideline for the management of
gout. Rheumatology (Oxford) 2007; 46(8):1372-4.
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