New analysis shows Novartis drug Gilenya® significantly reduced rate of brain volume loss across three large Phase III studies
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New analysis shows Novartis drug Gilenya® significantly reduced rate of brain
volume loss across three large Phase III studies
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* Data show reductions in rate of brain volume loss by about one-third
compared to interferon beta-1a IM or placebo in studies with over 3,600
patients with relapsing MS
* Gilenya is the first oral disease modifying treatment to show consistent
effect on brain volume loss, an important indicator of disease progression
* Analysis of FREEDOMS II, a Phase III study, confirms Gilenya consistently
reduces annualized relapse rates across disease activity, gender, age and
prior treatment
* Safety profile of Gilenya reinforced in patients treated up to four years;
overall more than 56,000 patients treated with Gilenya worldwide
Basel, March 21, 2013 - New data presented at the 65th annual meeting of the
American Academy of Neurology (AAN) show Gilenya(®) (fingolimod), the first oral
disease modifying therapy approved to treat relapsing forms of multiple
sclerosis (MS), significantly and consistently reduced the rate of brain volume
loss. Results also showed that Gilenya reduced annualized relapse rates across
important subgroups; and additional data reinforce Gilenya's safety profile in
patients treated up to four years.
"Loss of brain volume is a consequence of multiple sclerosis and is a key MRI
correlate of disease progression," said Dr. Timothy Wright, Global Head
Development, Novartis Pharmaceuticals AG. "The findings reported show the effect
of Gilenya across a variety of important disease measures and support evidence
for initiating early use of this highly effective treatment in patients with
relapsing MS."
Data shows consistent reduction in rate of brain volume loss
In a new analysis of over 3,600 patients from three large Phase III studies
(TRANSFORMS, FREEDOMS, and FREEDOMS II) Gilenya showed a significant reduction
in the rate of brain volume loss vs. a comparator - consistent with previously
reported results[1]. In the TRANSFORMS study over one year, Gilenya reduced the
rate of brain volume loss by -32% (p<0.001) compared to Avonex(®) (interferon
beta-1a IM), a commonly prescribed injectable treatment[1]. Over two years,
Gilenya reduced the rate of brain volume loss compared to placebo by 35%
(p<0.001) in the FREEDOMS study, and by 33% (p<0.001) in the FREEDOMS II study,
respectively[1].
The data also showed that brain volume, at baseline, consistently correlated
with the level of disease severity and disability. Lower brain volume was linked
with more severe disease and disability, while higher brain volume correlated
with less severe levels. In addition, traditional markers of disease activity
(such as MRI lesion counts) at baseline were predictive of the rate of brain
volume loss over two years.
New results highlight consistent efficacy and long-term safety profile
Separately, a recent subgroup analysis (n=1083) of FREEDOMS II, the third large
Phase III Gilenya study, supports the known efficacy of Gilenya treatment.
Specifically, results show Gilenya consistently reduced annualized relapse rates
(ARR) compared to placebo in patients with relapsing-remitting MS, across
gender, age, prior treatment, and baseline disease activity[2].
New extension data from FREEDOMS II (n=632) reinforce the known safety profile
of Gilenya in patients treated up to four years[3]. More than eight out of ten
patients (83%) completed the extension study, which identified no unexpected
safety concerns[3].
Gilenya was approved based on the largest Phase III program in relapsing-
remitting MS at the time of submission. With up to seven years of clinical trial
experience (Phase II and III) and over two years of real-world use, there is
increasing experience of Gilenya's long-term effectiveness and safety profile in
more than -56,000 patients worldwide[4].
About Gilenya
Gilenya is the first oral therapy approved to treat relapsing forms of MS and
the first in a new class of compounds called sphingosine 1-phosphate receptor
modulators[5],[6]. Gilenya is thought to act on inflammatory processes
implicated in the MS disease process[5],[6].
Data has shown significant efficacy with Gilenya in reducing relapses and
significant slowing of six-month disability progression sustained at four
years[7]. Nearly half of Gilenya patients were disease-free after one year of
treatment[8] and in the pivotal FREEDOMS study eight out of ten patients
remained on treatment at two years[9]. Gilenya is the only treatment shown to
consistently decrease brain volume loss, the best characterized magnetic
resonance imaging (MRI) predictor of long-term disability.
Gilenya has demonstrated superior efficacy compared to Avonex(®) (interferon
beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction
in annualized relapse rate (primary endpoint) at one year in a pivotal head-to-
head trial in patients with relapsing-remitting multiple sclerosis[10]. In a
post hoc sub-group analysis, Gilenya showed a 61% relative reduction in
annualized relapse rate compared to interferon-beta-1a (IM) at one year in
subgroups of patients with highly active relapsing-remitting MS not responding
to interferon treatment[11].
In clinical trials, Gilenya was generally well-tolerated with a manageable
safety profile. The most common side effects were headache, liver enzyme
elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related
side effects included transient, generally asymptomatic, heart rate reduction
and atrioventricular block upon treatment initiation, mild blood pressure
increase, macular edema and mild bronchoconstriction[9],[10]. 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[9],[10].
Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by express or implied discussions regarding potential new 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 in any market, or at any particular time. 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 clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; unexpected regulatory actions or delays or government regulation
generally; 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.
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 http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References:
[1] Cohen J. et al. Fingolimod-effect on brain atrophy and clinical/MRI
correlations in Three Phase 3 studies - TRANSFORMS, FREEDOMS and FREEDOMS II.
Abstract Presented at AAN, San Diego, March 2013.
[2] Goodin D. et al. Fingolimod reduces annualized relapse rates in patients
with relapsing-remitting multiple sclerosis: FREEDOMS II study subgroup
analysis. Abstract Presented at AAN, San Diego, March 2013.
[3] Vollmer T. et al. Long-term safety of fingolimod in patients with relapsing-
remitting multiple sclerosis: Results from phase 3 FREEDOMS extension study.
Abstract Presented at AAN, San Diego, March 2013.
[4] Novartis data on file.
[5] Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects
in the immune and the central nervous system. Br J Pharmacol
2009;158(5):1173-1182.
[6] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in
Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[7] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720)
efficacy in patients with relapsing-remitting multiple sclerosis receiving
continuous or placebo-fingolimod switched therapy for up to 4 years. Poster
presented at: 28th Congress of the European Committee for Treatment and Research
in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
[8] Khatri B. et al. Fingolimod treatment increases the proportion of patients
who are free from disease activity in multiple sclerosis compared to interferon
beta-1a: results from a phase 3 active controlled study (TRANSFORMS). Abstract
presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA.
Abstract PD5:006.
[9] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of
oral fingolimod in relapsing multiple sclerosis. N Engl J Med.
2010;362(5):387-401.
[10] Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral
fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl
J Med. 2010;362(5):402-415.
[11] Havrdová E, et al. Clinical outcomes in subgroups of patients with highly
active relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720):
Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at
ECTRIMS, Amsterdam, October 2011.
Avonex(® )is a registered trademark of Biogen Idec.
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Datum: 21.03.2013 - 07:15 Uhr
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