Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya® vs. interferon beta-1a
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Novartis International AG /
Novartis PARADIGMS data show children and adolescents with MS had an 82% lower
relapse rate with Gilenya® vs. interferon beta-1a
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* PARADIGMS data also show patients treated with Gilenya had significantly
fewer new brain lesions vs. those on interferon beta-1a
* Currently there are no specifically approved disease modifying therapies for
children and adolescents with MS, a population at high risk of long-term
disability
* MS is a highly debilitating disease which touches every aspect of young
patients' daily lives, from school performance to family relations and
friendships
The digital press release with multimedia content can be accessed here:
Basel, October 28, 2017 - Novartis today announced full results from the
positive Phase III PARADIGMS study, investigating the safety and efficacy of
Gilenya(®) (fingolimod) vs. interferon beta-1a, in children and adolescents
(ages 10 to 17) with multiple sclerosis (MS). Treatment with oral Gilenya
resulted in an 82% reduction in the rate of relapses (annualized relapse rate)
over a period of up to two years, compared to interferon beta-1a intramuscular
injections (p <0.001)[1]. PARADIGMS is the first ever controlled, randomized
trial specifically designed for pediatric MS. The results have been presented at
the 7(th) Joint European and Americas Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS-ACTRIMS) meeting on October 28, 2017 in Paris,
France.
"Pediatric MS patients experience more frequent relapses and are more likely to
accumulate physical disability at an earlier age than patients diagnosed as
adults," said Dr. Tanuja Chitnis, Principle Investigator for PARADIGMS and
Director of the Partners Pediatric Multiple Sclerosis Center, Massachusetts
General Hospital, Boston, US, and Scientist, Ann Romney Center, Brigham and
Women's Hospital, Boston, US. "Yet, current therapies are limited to drugs that
have not been tested in a controlled manner in this age group. PARADIGMS was
uniquely designed for this patient population. Its results signify an important
step towards a potential new treatment that could improve the lives of these
young patients."
Additional data from the study demonstrated:
* A significant reduction in the number of new / newly enlarging T2 and Gd-T1
lesions in the brain of Gilenya treated patients compared to those treated
with interferon beta-1a, as measured by magnetic resonance imaging (MRI)[1].
The number and volume of lesions are associated with increased relapses and
disability progression[2].
* Individuals treated with Gilenya had significantly less brain shrinkage
(measured by MRI as brain volume loss), compared to those treated with
interferon beta-1a[1]. Brain shrinkage in adults is associated with the loss
of physical and cognitive function[3].
* The safety profile of Gilenya was overall consistent with that seen in
previous clinical trials, with more adverse events reported in the
interferon group[1].
* In an additional analysis, Gilenya significantly delayed disability
progression, defined as Confirmed Disability Progression (CDP), compared to
interferon beta-1a[1].
"There is already substantial evidence that Gilenya is an effective treatment
that improves long-term outcomes for adults with relapsing MS. We are delighted
that PARADIGMS has shown such meaningful benefits for children and adolescents
with MS," said Vas Narasimhan, Global Head of Drug Development and Chief Medical
Officer, Novartis. "This pioneering study demonstrates our continued commitment
to providing new treatment options to MS patients with the highest need. We look
forward to working with health authorities and preparing for submission."
Gilenya is not currently approved for the treatment of pediatric MS. Novartis is
working on submission with health authorities worldwide.
About the Phase III PARADIGMS study
The Phase III PARADIGMS study (NCT01892722) is a flexible duration (up to two
years), double-blind, randomized, multi-center study to evaluate the safety and
efficacy of oral Gilenya compared to interferon beta-1a in children and
adolescents with a confirmed diagnosis of multiple sclerosis (MS), followed by a
five-year open label extension phase[4]. The study enrolled 215 children and
adolescents with MS, between the ages of 10 and 17 years with an Expanded
Disability Status Scale (EDSS) score between 0 and 5.5[4]. Patients were
randomized to receive once-daily oral Gilenya (0.5 mg or 0.25 mg, dependent on
patients' body weight) or intramuscular interferon beta-1a once weekly[4].
The primary endpoint of the study was the frequency of relapses in patients
treated up to 24 months (annualized relapse rate)[4]. Secondary endpoints
include the number of new or newly enlarged T2 lesions, Gadolinium enhancing T1
lesions, safety and the pharmacokinetic properties of Gilenya, all measured
throughout the treatment period[4].
The Phase III PARADIGMS study was conducted in 87 sites over 25 countries, and
was designed in partnership with the US Food and Drug Administration, the
European Medicines Agency and the International Pediatric Multiple Sclerosis
Study Group.
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[5]. In adults, there are three types
of MS: relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and
primary progressive MS (PPMS)[6]. In children, RRMS accounts for nearly all
cases (approximately 98 percent)[7].
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, of which between
three and five percent are estimated to be children[8],[9].
About Gilenya (fingolimod) in adults
Gilenya (fingolimod) is an oral disease-modifying therapy (DMT) that is highly
efficacious at controlling disease activity in relapsing multiple sclerosis
(RMS)[10]. Gilenya has a reversible lymphocyte redistribution effect targeting
both focal and diffuse central nervous system (CNS) damage caused by
MS[11],[12]. Long-term clinical trial and real-world evidence and 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[13],[14].
Gilenya impacts four key measures of RMS disease activity: relapses, MRI
lesions, brain shrinkage (brain volume loss) and disability
progression[15],[16]. Its effectiveness on all of these measures has been
consistently shown in multiple controlled clinical studies and in the real-world
setting. 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[17],[18].
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[10],[19].
Gilenya has been used to treat more than 217,000 patients in both clinical
trials and the post-marketing setting, with approximately 480,000 years of
patient experience[20].
About Novartis in Multiple Sclerosis
Alongside Gilenya (fingolimod, an S1P modulator), Novartis' multiple sclerosis
(MS) portfolio includes Extavia(®) (interferon beta-1b for subcutaneous
injection) which 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), under investigation in MS,
and OMB157 (ofatumumab), a fully human monoclonal antibody under investigation
in relapsing MS. OMB157 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.
*Copaxone(®) is a registered trademark of Teva Pharmaceutical Industries Ltd.
Disclaimer
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expectations regarding future events, and are subject to significant known and
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actual results may vary materially from those set forth in the forward-looking
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products described in this press release will be submitted or approved for sale
or for any additional indications or labeling in any market, or at any
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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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
121,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Chitnis T et al. PARADIGMS: A Randomised Double-blind Study of Fingolimod
Versus Interferon ß-1a in Paediatric Multiple Sclerosis. Late breaking news oral
presentation presented at: the 7th Joint ECTRIMS-ACTRIMS meeting on October
28, 2017, Paris, France.
[2] Sormani MP and Bruzzi P. MRI lesions as a surrogate for relapses in
multiple sclerosis: a meta-analysis of randomized trials. Lancet Neurol.
2013;12(7):669-76.
[3] Popescu V et al; on behalf of the MAGNIMS Study Group. Brain atrophy and
lesion load predict long term disability in multiple sclerosis. J Neurol
Neurosurg Psychiatry. 2013;84:1082-1091.
[4] Clinical Trials. Safety and efficacy of fingolimod in pediatric
patients with multiple
sclerosis. https://clinicaltrials.gov/ct2/show/NCT01892722 (link is external).
Accessed October 2017.
[5] PubMed Heath. Multiple Sclerosis (MS).
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/ (link is external).
Accessed October 2017.
[6] MS Society. Types of MS. https://www.mssociety.org.uk/what-is-
ms/types-of-ms (link is external). Accessed October 2017.
[7] Waldman A et al. Pediatric multiple sclerosis. Neurology.
2016;87(9):S74-S81.
[8] Patel Y et al. Pediatric multiple sclerosis. Ann Indian Acad Neurol.
2009;12(4):238-245.
[9] 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 October 2017.
[10] Gilenya US Prescribing Information.
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/gileny
a.pdf (link is external). Accessed October 2017.
[11] Brinkmann V et al. FTY720 (fingolimod) in Multiple Sclerosis:
therapeutic effects in the immune and the central nervous system. Br J
Pharmacol. 2009;158(5):1173-1182.
[12] De Stefano N et al. Effect of fingolimod on diffuse brain tissue damage
in relapsing-remitting multiple sclerosis patients. Mult Scler Relat Disord.
2016;7:98-101.
[13] Warrender-Sparkes M et al. The effect of oral immunomodulatory therapy
on treatment uptake and persistence in multiple sclerosis. Mult Scler.
2016;22(4):520-532.
[14] Khatri B et al. Comparison of fingolimod with interferon beta-1a in
relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS
study. Lancet Neurol. 2011;10(6):520-529.
[15] Giovannoni G et al. "No evident disease activity": The use of combined
assessments in the management of patients with multiple sclerosis. Mult Scler.
2017. Doi 10.1177/1352458517703193.
[16] De Stefano N et al. Effect of Fingolimod on Brain Volume Loss in
Patients with Multiple Sclerosis. CNS Drugs. 2017;31(4):289-305.
[17] Kappos L et al. Inclusion of brain volume loss in a revised measure of
'no evidence of disease activity' (NEDA-4) in relapsing-remitting multiple
sclerosis. Mult Scler. 2016;22(10):1297-1305.
[18] Lizac N et al. Highly active immunomodulatory therapy ameliorates
accumulation of disability in moderately advanced and advanced multiple
sclerosis. J Neurol Neurosurg Psychiatry. 2017;88(3):196-203.
[19] Gilenya EMA Summary of Product Characteristics.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002202/WC500104528.pdf (link is external). Accessed
October 2017.
[20] Novartis data on file.
# # #
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Datum: 28.10.2017 - 08:55 Uhr
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News-ID 565667
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