Novartis International AG : Novartis receives positive CHMP opinion for
Ilaris® to treat patients whose acute gouty arthritis cannot be managed with
standard of care
Novartis International AG / Novartis receives positive CHMP opinion for
Ilaris® to treat patients whose acute gouty arthritis cannot be managed with
standard of care . Processed and transmitted by Thomson Reuters ONE. The
issuer is solely responsible for the content of this announcement.
*CHMP endorsed the use of Ilaris in patients with acute gouty arthritis,
who suffer frequent attacks and for whom current treatments are unsuitable
*Ilaris, the only approved fully human monoclonal antibody targeting
interleukin-1 beta (IL-1 beta), inhibits inflammation through sustained
neutralization of IL-1 beta
*Current therapies do not offer relief to certain groups of gouty arthritis
patients, particularly those with serious comorbidities, during their
severe, crippling attacks,
Basel, January 18, 2013 - Novartis announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
has adopted a positive opinion for the use of 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
"Novartis welcomes the decision by the CHMP in support of the approval of
Ilaris in the EU," said David Epstein, Division Head of Novartis
Pharmaceuticals. "When approved, lIaris will provide a new treatment option
for patients who have endured frequent and crippling gouty arthritis attacks
and where existing therapies do not offer relief. We look forward to receiving
the final decision from the European Commission in the coming months."
Ilaris is the only available fully human monoclonal antibody that specifically
targetsIL-1 beta and, when approved, will offer patients suffering gouty
arthritis attacks rapid pain relief via a single subcutaneous injection of 150
Gouty arthritis, commonly referred to as gout, is a serious, chronic and
progressive inflammatory disease that generally affects 1 to 4% of
adults[3-7]. Gouty arthritis 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,,,.
When approved, Ilaris will be 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'. Since urate lowering therapy (ULT) is
generally advised in these patients, Ilaris may provide sufficient pain relief
to allow initiation or continuation of ULT.
Data from two Phase III trials and their extensions, which informed the CHMP's
positive opinion for Ilaris in gouty arthritis, showed that patients treated
with Ilaris experienced significantly greater pain relief compared to the
injectable steroid triamcinolone acetonide (TA). 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.
The European Commission generally follows the recommendations of the CHMP and
usually delivers its final decision within three months of the CHMP
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 12weeks in duration followed by 12
week double-blind initial extensions.
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.
Pain intensity in the overall study population was statistically significantly
lower for Ilaris 150mg compared to TA at 72hours (-10.7mm, p<0.0001), with
an absolute mean decrease in VAS score of approximately -50mm. Reduction in
pain was observed as early as 6hours after dosing in both groups. A
statistically significant difference between treatments was observed from
24hours to 7 days. Ilaris also reduced the risk of subsequent attacks.
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.
A sub-analysis of these studies included 101 patients unable to use NSAIDs and
colchicine, and on stable ULT or unable to use ULT. Pain relief was similar to
that shown in the total study population (-10.2mm for Ilaris 150mg compared
with TA at 72hours, p=0.0208).
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.
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.
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), a suite of rare, life-long, genetic, autoinflammatory
diseases with debilitating symptoms. Ilaris is being investigated in a
number of inflammatory conditions, which include, systemic juvenile idiopathic
arthritis (SJIA), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome
(TRAPS), 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
About Gouty Arthritis
Gouty arthritis is the most common form of inflammatory arthritis in
adults,. The chronic and progressive disease is characterized by
recurrent attacks in select joints. These 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,. The intense
inflammatory response associated with these attacks may cause severe pain and
debilitating symptoms that can last a week or more,,.
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,,. As a result, there is a significant unmet medical need
among individuals with gouty arthritis.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "positive opinion," "endorsed," "will,"
"look forward to," "generally follows," "recommendation," "would," 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; competition in general; government,
industry and general public pricing pressures; unexpected manufacturing
issues; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; 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.
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,
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