Novartis therapy GilenyaTM reduced the risk of MS disability progression regardless of treatment history or disease severity, new analysis shows
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Novartis International AG /
Novartis therapy GilenyaTM reduced the risk of MS disability progression
regardless of treatment history or disease severity, new analysis shows
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* Gilenya delayed the progression of disability both for patients who were
previously treated for their MS and for patients who had not received prior
treatment
* 11 scientific abstracts on Gilenya efficacy and safety will be presented at
the American Academy of Neurology annual meeting
* Gilenya, first oral in a new class of drugs called S1P receptor modulators,
is approved in more than 35 countries including US, Canada and Germany
Basel, April 11, 2011- A new analysis demonstrated that Gilenya(TM) (fingolimod)
reduced the risk of disability progression in patients with relapsing-remitting
multiple sclerosis (RRMS), regardless of treatment history. This analysis of the
phase III two-year FREEDOMS study is one of 11 abstracts on Gilenya being
presented at the 63(rd) annual meeting of the American Academy of Neurology
(AAN).
"In developing Gilenya, Novartis initiated a large clinical trial program that
would provide the MS community with robust data to define the efficacy and
safety profile of this oral treatment for relapsing forms of MS, " said Trevor
Mundel, MD, Global Head of Development at Novartis Pharma AG. "Our scientific
presence at AAN is evidence of our commitment to continued research and ongoing
reporting of clinical information to physicians and patients."
The primary endpoint for the two-year FREEDOMS study was relapse rate, in which
Gilenya reduced relapses by 54% compared to placebo (p<0.001). In a key
secondary endpoint, Gilenya showed a 30% reduction (p<0.05) in the risk of 3-
month confirmed disability progression as compared to placebo over two years.
The FREEDOMS analysis presented this week at AAN showed that 0.5 mg Gilenya-
treated patients who were new to therapy (n = 493) had a 37% reduction in the
risk of 3-month confirmed disability progression compared to placebo (HR:
0.63; 95% CI: 0.41-0.95) while those previously treated with alternate therapies
(n = 350) Gilenya 0.5 mg led to a 30% reduction in risk (HR: 0.70; 95% CI:
0.43-1.14). Consistent favorable effects on disability progression were observed
for Gilenya-treated patients compared to placebo for subgroups defined by age,
gender, and disease severity as defined by EDSS score, relapse activity prior to
study, magnetic resonance imaging (MRI) lesion burden or lesion activity at the
time of the start of the study.
"These data provide deeper insights into the effect of Gilenya in significantly
reducing MS disability progression across the broad range of patient
subpopulations that this analysis evaluated, " said Virginia Devonshire, MD
Director of the University of British Columbia MS Clinic and a FREEDOMS trial
investigator.
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first oral
treatment in a new class of drugs called sphingosine 1-phosphate receptor (S1PR)
modulators. Approved in more than 35 countries including US, Canada and Germany,
Gilenya has been studied in phase III clinical trials of over 2500 patients with
relapsing-remitting MS. In MS, the immune system damages the myelin sheath that
protects nerve fibers in the central nervous system (CNS), which includes the
brain and spinal cord. As shown in animal models, Gilenya stops many of the
white blood cells (lymphocytes) from leaving the lymph nodes. Exactly how
Gilenya works in MS is unknown, but it is thought that it results in fewer white
blood cells entering the CNS to attack and damage the myelin sheath. If Gilenya
treatment is stopped for any reason, the number of white blood cells circulating
in the body increases over the first few days and gradually returns to normal
within 1 to 2 months.
The most common side effects are 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.
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.
About Multiple Sclerosis
While there is still much to be understood about multiple sclerosis, it is
thought to be an autoimmune disease of the central nervous system that is
chronic, progressive and often disabling. It affects over 400,000 Americans and
more than 2.1 million people worldwide. The most common forms of the disease,
relapsing forms of MS, are characterized by exacerbations or flare-ups
interspersed with periods of disease remission. Typically, MS strikes in early
adulthood between the ages of 20 and 50 and affects women twice as frequently as
men.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "risk, " "will, " "would, " "commitment, " or similar
expressions, or by express or implied discussions regarding potential future
indications or labeling for Gilenya, or regarding potential future revenues from
Gilenya. 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 Gilenya 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 any additional indications or labeling. Nor can there be any guarantee that
Gilenya will achieve any particular levels of revenue in the future. In
particular, management´s expectations regarding Gilenya could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; government, industry and general public pricing pressures,
including governmental reimbursement issues; competition in general; unexpected
clinical trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; 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 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, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. 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 119,000 full-time-equivalent associates (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
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