Novartis receives approval in Japan for two innovative therapies, Gilenya® in MS and Ilaris® in CAPS
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Novartis receives approval in Japan for two innovative therapies, Gilenya® in MS
and Ilaris® in CAPS
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* Gilenya first high efficacy oral therapy approved in Japan for the
prevention of relapse and delay of progression of physical disability in
adults with multiple sclerosis (MS)
* Ilaris the first drug approved in Japan for the treatment of cryopyrin-
associated periodic syndrome (CAPS), a rare and debilitating auto
inflammatory disease
* Approvals demonstrate ongoing Novartis commitment to bringing innovative
treatments to patients in Japan
Basel, September 27, 2011 - Novartis announced today that it received regulatory
approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) for
once-daily Gilenya (fingolimod) 0.5mg for the prevention of relapse and delay of
progression of physical disability in adults with multiple sclerosis (MS), and
for Illaris (canakinumab) subcutaneous (s.c.) injection 150mg, the first
treatment for adults and children with cryopyrin-associated periodic syndrome
(CAPS).
In the US, Gilenya is approved for relapsing forms of MS. In the EU, Gilenya is
approved for people with highly active relapsing-remitting MS despite treatment
with beta interferon, or in patients with rapidly evolving severe relapsing-
remitting MS.
The Ilaris approval is also extended to include all CAPS disease phenotypes:
familial cold auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and
neonatal-onset multisystem inflammatory disease (NOMID).
"Today's announcement demonstrates our continued commitment to bringing
innovative new treatments to patients where there is significant unmet need,"
said David Epstein, Head of the Pharmaceuticals Division of Novartis.
"Strengthening our presence in Japan is a major priority for Novartis and we are
pleased that the Japanese Health Authority have acknowledged the positive
benefit-risk profiles of both Gilenya and Ilaris."
The Japanese approval of Gilenya was based on the largest clinical trial program
submitted to date for a new MS drug, including Phase II data in Japan, and
comprised data from clinical studies showing significant efficacy in reducing
relapses, the risk of disability progression, and the number of brain lesions
detected by magnetic resonance imaging (MRI), a measure of disease activity[1-
4].
MS, an autoimmune disease, is designated as a specified disease by the Ministry
of Health, Labor and Welfare and reportedly affects approximately 14,000
patients diagnosed and registered in Japan.[5]
"Until now, there has been only interferon beta as an approved treatment for
prevention of relapse in patients with MS in Japan," said Dr. Yasuto Itoyama,
Director, National Center Hospital, National Center of Neurology and Psychiatry.
"Fingolimod has a novel mechanism of action that is different from existing
drugs and its high efficacy has been confirmed in clinical studies in Japan and
overseas. With its convenience as a once-daily oral formulation, we expect that
fingolimod will become an important treatment option for MS patients in Japan."
Gilenya (fingolimod), licensed from Mitsubishi Tanabe Pharma Corporation, is the
first in a new class of drugs that modulates sphingosine 1-phosphate (S1P)
receptors[1],[2]. It has been approved in more than 50 countries, including the
US, Australia, Canada, EU members, Switzerland, Brazil, and Japan.
Gilenya demonstrated superior efficacy in relapse rates compared to interferon-
beta-1a (IM), a commonly prescribed treatment, showing a 52% relative reduction
in annualized relapse rate at one year in a pivotal head-to-head trial in
patients with relapsing-remitting multiple sclerosis[1].( )In a two-year,
placebo controlled study, Gilenya showed a 30% relative reduction in risk of
sustained disability progression over two years versus placebo, as measured by
the EDSS (Expanded Disability Statue Scale) and confirmed after three
months[2].( )
In clinical trials, the most common Gilenya side effects were headache, liver
enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-
related side effects include transient, generally asymptomatic, heart rate
reduction and atrioventricular block upon treatment initiation, mild blood
pressure increase, macular edema, and mild bronchoconstriction[1-4].
The rates of infections overall, including serious infections, were comparable
among treatment groups, although a slight increase in lower respiratory tract
infections (primarily bronchitis) was seen in patients treated with Gilenya. The
number of malignancies reported across the clinical trial program was small,
with comparable rates between the Gilenya and control groups[1-4].
Ilaris is a fully human monoclonal antibody that binds selectively to
interleukin-1 beta (IL-1 beta), one of the inflammatory cytokines, neutralizing
its activity[6]. Ilaris is administered by subcutaneous injection once every
eight weeks[6].
CAPS is a disease that comprises three different phenotypes, FCAS, MWS and
NOMID, that are caused by the overproduction of IL-1 beta which induces an
inflammatory reaction[7-9]. Onset of symptoms starts at birth or childhood, and
various symptoms such as fever, joint pain, rash, headaches, fatigue and
conjunctivitis recur throughout patients' lives[7],[10]. In severe cases these
may induce impaired hearing and vision, bone and joint deformities and
nephropathy[7],[10].
"Since no treatment was established for CAPS in the past and only symptomatic
therapies were available in Japan, the needs of patients and their families had
not been sufficiently met," said Professor Shunpei Yokota of the Department of
Child Health and Development, Yokohama City University School of Medicine. "This
is a very exciting development for the treatment of CAPS, as Ilaris produces a
rapid remission of symptoms and inherently has the potential to improve
patients' quality of life and their outcome."
The clinical trial program of Ilaris for CAPS in Japan started in October 2009
and the drug received orphan drug status in August 2010. The submission in Japan
was supported by a clinical program that included a local clinical study
involving 19 patients and it comprised data from both non-Japanese and Japanese
CAPS patients. In this study, Ilaris rapidly produced complete remission of
symptoms in 94.7% and 100% of patients, at 24 and 48 weeks of administration
respectively. Ilaris was generally well tolerated and there was no consistent
pattern of adverse events apart from a slight increase in upper respiratory
infections. The most common adverse events were nasopharyngitis and stomatitis.
Ilaris (canakinumab) is approved in more than 50 countries, including the EU, US
and Switzerland for the treatment of adults and children as young as four with
CAPS. Canakinumab is also being studied in other diseases in which IL-1 beta
plays a key role in causing inflammation, such as JIA, gouty arthritis and
secondary prevention of cardiovascular events. Not all potential patients with
these diseases would be eligible for treatment with canakinumab, if approved.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "priority," "expect," "will," "potential,"
or similar expressions, or by express or implied discussions regarding potential
future marketing approvals for Gilenya, potential future marketing approvals or
new indications or labeling for Ilaris, or regarding potential future revenues
from Gilenya or Ilaris, or from the sales of Pharmaceutical Division products in
Japan generally. 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 to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that Gilenya will be submitted or approved for sale in
any additional markets, or at any particular time. Nor can there be any
guarantee that Ilaris will be submitted or approved sale in any additional
markets, or for any additional indications or labeling in any market, or at any
particular time. Nor can there be any guarantee that Gilenya or Ilaris, or the
Novartis Pharmaceuticals Division portfolio in Japan will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding these products 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,
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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group's continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 121,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
References
[1] Cohen et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Engl J Med. Vol.362 No.5, Feb 4, 2010 (printed version).
[2] Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing
Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010 (printed version).
[3] O'Connor P, Comi G, Montalban X, et al. Oral fingolimod (FTY720) in multiple
sclerosis: Two-year results of a phase II extension study. Neurology
2009;72(1):73-79.
[4] Comi G, O'Connor P, Montalban X, et al. Phase II study of oral fingolimod
(FTY720) in multiple sclerosis: 3-year results. Mult Scler;16(2):197-207.
[5] Public Health Report, Statistics and Information Department, Ministry of
Health, Labor and Welfare Secretariat, 346, 2009
[6] Ilaris [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals
Corp; 2009.
[7] NOMID Alliance (2008). CAPS Cryopyrin Associated Periodic Syndromes
(Internet).http://www.nomidalliance.net/downloads/finalCAPSbrochure_web.pdf Last
accessed 22 August 2010.
[8] Drenth JP, van der Meer JW. The inflammasome--a linebacker of innate
defense. N Engl J Med 2006; 355(7):730-2.
[9] Lachmann HJ, Lowe P, Felix SD, et al. In vivo regulation of interleukin
1beta in patients with cryopyrin-associated periodic syndromes. J Exp Med
2009; 206(5):1029-36.
[10] Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al. Use of canakinumab
in the cryopyrin-associated periodic syndrome. N Engl J Med
2009; 360(23):2416-25.
# # #
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Datum: 27.09.2011 - 07:25 Uhr
Sprache: Deutsch
News-ID 69548
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