New Novartis data presented at ECTRIMS show benefit of Gilenya® on patient disability progression at 10 years
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Novartis International AG /
New Novartis data presented at ECTRIMS show benefit of Gilenya® on patient
disability progression at 10 years
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* ACROSS study shows that patients with relapsing remitting multiple sclerosis
(RRMS) continuously treated with Gilenya(®) (fingolimod) had significantly
lower disability progression compared to those whose treatment was
interrupted
* Fewer patients who stayed on Gilenya therapy for eight to 10 years had
developed secondary progressive MS compared to those who discontinued it
* Almost 60% of patients enrolled in ACROSS remained on Gilenya treatment at
10 years, demonstrating long-term persistence[1]
The digital press release with multimedia content can be accessed here:
Basel, September 16, 2016 - Novartis today announced new data from the ACROSS
study, which assessed 10-year disability outcomes in people with relapsing
remitting multiple sclerosis (RRMS) treated with Gilenya(® )(fingolimod). These
results provide supportive evidence of the long-term effectiveness of continuous
Gilenya treatment on controlling disability progression. Full results are being
presented at the 32(nd) Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS), in London, UK.
ACROSS is a single visit observational study of 175 individuals previously
enrolled in the Phase II study of fingolimod in RRMS.[1] The study met its
primary endpoint of a significantly lower change from baseline at 10 years in
patients' Expanded Disability Status Scale (EDSS) score with continuous versus
non-continuous Gilenya treatment (0.55 versus 1.21, respectively; p=0.0155).[1]
Analyses of key secondary endpoints showed that after 10 years, the risk of
progression to secondary progressive MS (SPMS) was reduced by 66.2% in patients
who remained on Gilenya treatment for at least eight years, compared to those
who did not.[1] There was also a significant four-fold delay in the time to use
of a wheelchair.[1] Almost 60% (59.4%) of patients in ACROSS stayed on Gilenya
at 10 years, demonstrating persistence of treatment over the long term.[1]
"Multiple sclerosis is a debilitating, life-long disease, and greatly impacts
how individuals are able to go about their daily lives," said Vasant Narasimhan,
Global Head Drug Development and Chief Medical Officer for Novartis. "The ACROSS
data add to our understanding of the long-term use of Gilenya as a highly-
effective treatment option for people with relapsing remitting MS."
MS is a chronic neurological disease, associated with worsening physical and
cognitive (e.g. memory) disability over time that limits sufferers' abilities to
go about everyday tasks.[2] Limiting disability progression as early on in the
disease process as possible is an important treatment goal in MS and can help
improve the long-term outcomes of people with the condition, as well as delaying
progression to SPMS.[3],[4]
About the ACROSS study
The ACROSS study is a multi-center, single visit, 10-year observational study
evaluating the long-term efficacy of Gilenya in relapsing remitting MS (RRMS)
over a 10-year follow-up period. The study included 175 people with RRMS who
were previously enrolled in the Phase II D2201 study, evaluating the efficacy,
safety and tolerability of fingolimod in RRMS. Patients enrolled in ACROSS were
divided into the continuous Gilenya treatment group (defined as Gilenya
treatment for at least eight years) and the non-continuous Gilenya treatment
group (defined as Gilenya treatment for less than eight years).[1]
The primary objective was to evaluate whether continuous use of Gilenya over 10
years reduces the progression of disability, as measured by the mean Expanded
Disability Status Scale (EDSS) score, compared to shorter treatment duration.[1]
Key secondary objectives included the proportion of people with disability
progression, the time to first use of a wheelchair, and the proportion of people
who developed SPMS with continuous versus non-continuous Gilenya treatment at
10 years.[1]
As in any study without parallel control, biases related to the design of the
study need to be considered.
About Gilenya (fingolimod)
Gilenya is an oral disease-modifying therapy (DMT) that is highly efficacious at
controlling disease activity in relapsing MS (RMS).[5] Long-term experience has
shown Gilenya treatment to be convenient for individuals to incorporate into
everyday life, leading to high treatment satisfaction, long-term persistence,
and ultimately, improved long-term outcomes for people with RMS.[5]-[10]
Gilenya impacts four key measures of disease activity: relapses, MRI lesions,
brain shrinkage (brain volume loss) and disability progression.[5],[6] Its
effectiveness on all of these measures has been consistently shown in multiple
controlled clinical studies and in the real-world
setting.[5],[11],[12],[13],[14] Studies have shown its safety and high efficacy
to be sustained over the long term, demonstrating that switching to Gilenya
treatment as early in the disease course as possible can be beneficial in
helping to preserve individuals' function.[13],[15]
Gilenya is approved in the US for the first-line treatment of relapsing forms of
MS in adults and in the EU for adult patients with highly-active relapsing
remitting MS (RRMS) defined as either high disease activity despite treatment
with at least one DMT, or rapidly-evolving severe RRMS.[15]
Gilenya has been used to treat approximately 155,000 patients in both clinical
trials and the post-marketing setting, with approximately 343,000 years of
patient experience.[16]
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disorder of the central nervous system
(CNS) that disrupts the normal functioning of the brain, optic nerves and spinal
cord through inflammation and tissue loss.[17] There are three types of MS:
relapsing remitting MS (RRMS), secondary progressive MS (SPMS) and primary
progressive MS (PPMS).[18] The evolution of MS results in an increasing loss of
both physical and cognitive (e.g. memory) function. This has a substantial
negative impact on the lives of the approximately 2.3 million people worldwide
affected by MS.[19]
About Novartis in Multiple Sclerosis
The Novartis multiple sclerosis (MS) portfolio includes Gilenya, which is
indicated for relapsing forms of MS and also in development for pediatric MS.
Extavia(®) (interferon beta-1b for subcutaneous injection) is approved in the US
for the treatment of relapsing forms of MS. In Europe, Extavia is approved to
treat people with relapsing remitting MS, secondary progressive MS (SPMS) with
active disease and people who have had a single clinical event suggestive of MS.
Investigational compounds include BAF312 (siponimod) in development in SPMS, and
ofatumumab (OMB157), a fully human monoclonal antibody in development for
relapsing MS. Ofatumumab targets CD20, and is currently being investigated in
two Phase III pivotal studies.
In the US, the Sandoz Division of Novartis markets Glatopa(®) (glatiramer
acetate injection) 20mg/mL, the first generic version of Teva's Copaxone(®)*
20mg.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "goal," "can," "in development," "investigational," "being
investigated," or similar terms, or by express or implied discussions regarding
potential new indications or labeling for Gilenya or Extavia, potential
marketing approvals for BAF312 and OMB157, or regarding potential future
revenues from Gilenya, Extavia, Glatopa, BAF312 and OMB157. You should not place
undue reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management regarding future events, and
are subject to significant known and unknown risks and uncertainties. Should one
or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that Gilenya
or Extavia will be submitted or approved for any additional indications or
labeling in any market, or at any particular time. Neither can there be any
guarantee that BAF312 or OMB157 will be approved for sale in any market, or at
any particular time. Nor can there be any guarantee that any of Gilenya,
Extavia, Glatopa, BAF312 or OMB157 will be commercially successful in the
future. In particular, management's expectations regarding such products and
investigational compounds could be affected by, among other things, the
uncertainties inherent in research and development, including unexpected
clinical trial results and additional analysis of existing clinical data;
unexpected regulatory actions or delays or government regulation generally; the
company's ability to obtain or maintain proprietary intellectual property
protection; general economic and industry conditions; global trends toward
health care cost containment, including ongoing pricing pressures; unexpected
safety, quality or manufacturing issues, and other risks and factors referred to
in Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 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
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
*Copaxone(®) is a registered trademark of Teva Pharmaceutical Industries Ltd.
References
[1] Derfuss T et al. The ACROSS Study: Long-term efficacy of fingolimod in patients with RRMS
(follow-up at 10 years). Poster presented at: 32(nd) Congress of the European Committee for
Treatment and Research in Multiple Sclerosis; September 14-17, 2016; London, UK. Poster 1215.
[2] National MS Society. MS Symptoms. http://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms
(link is external). Accessed August 2016.
[3] MS Society. Early treatment. https://www.mssociety.org.uk/earlytreatment (link is external).
Accessed August 2016
[4] National Multiple Sclerosis Society. Frequently asked questions about SPMS.
http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Secondary-progressive-MS/Frequently-
Asked-Questions-about-SPMS (link is external). Accessed August 2016.
[5] Cohen JA et al. Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS.
J Neurol. 2013; 260(8):2023-2032.
[6] 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.
[7] Montalban et al. Long-term efficacy of fingolimod in patients with relapsing-remitting multiple
sclerosis previously treated with interferon beta-1a or disease-modifying therapies: A Post-hoc
analysis of the TRANSFORMS 4.5 year extension study. European Neurological Society, June
10, 2013 P539.
[8] Cohen JA et al. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis:
results from the extension of the randomized TRANSFORMS study. J Neurol Neurosurg Psychiatry.
2015; 0:1-8
[9] De Stefano N et al. Proportion of patients with BVL comparable to healthy adults in fingolimod
phase 3 MS studies. Abstract presented at: 66th AAN Annual Meeting; April 26 - May 3, 2014;
Philadelphia, Pennsylvania. Oral session S13:006.
[10] Lapierre Y et al. Canadian experience with fingolimod: adherence to treatment and monitoring. Can
J Neurol Sci. 2016; 43:278-283
[11] Fox E et al, on behalf of EPOC study investigators, Outcomes of switching directly to oral
fingolimod from injectable therapies: Results of the randomized, open-label, multicenter,
Evaluate Patient Out Comes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord.
2014; 3(5): 607-619.
[12] Cohen JA et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N
Engl J Med. 2010: 362:402-15.
[13] Khatri B et al. Comparison of fingolimod with interferon beta-1-a in relapsing-remitting multiple
sclerosis: a randomized extension of the TRANSFORMS study. The Lancet Neurology.
2011; 10(6);520-529
[14] Cascione M. et al. Randomized, open-label study to evaluate patient-reported outcomes with
fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis:
EPOC study rationale and design. Journal of Medical Economics. 2013; 16(7);859-865.
[15] He A. et al. Comparison of switch to fingolimod or interferon beta/ glatiramer acetate in active
multiple sclerosis. JAMA Neurol. 2015; 72(4):405-413.
[16] Data on file. Novartis Pharmaceuticals.
[17] PubMed Heath. Multiple Sclerosis (MS). http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/ (link
is external). Accessed August 2016.
[18] European Medicines Agency. EMA guidelines for the investigation of MS.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/10/WC500133438.pdf
(link is external). Accessed April 2016.
[19] Multiple sclerosis international federation. Atlas of MS 2013. https://www.msif.org/wp-
content/uploads/2014/09/Atlas-of-MS.pdf (link is external). Accessed August 2016.
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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