Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years
(Thomson Reuters ONE) -
Novartis International AG /
Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease
activity' (NEDA-4) analysis in MS patients over seven years
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* NEDA-4 - no evidence of disease activity based on four parameters -
relapses, MRI lesions, brain shrinkage and disability progression - is a
comprehensive measure of MS disease control
* 31.2% to 44.8% of patients continuously treated with Gilenya in the FREEDOMS
core and extension trials achieved NEDA-4 in each of the years three to
seven
* Separate analysis confirmed NEDA-4 status in the first year is a better
predictor of long-term outcomes than an assessment of three parameters
(relapses, MRI lesions and disability progression)
The digital press release with multimedia content can be accessed here:
Basel, October 8, 2015 - Novartis announced today a new analysis from the phase
III FREEDOMS and FREEDOMS II trials reinforcing the long-term efficacy profile
of Gilenya(®) (fingolimod). The analysis evaluated the proportion of Gilenya
patients with relapsing multiple sclerosis (RMS) achieving 'no evidence of
disease activity' (NEDA-4) every year over seven years[1]. NEDA-4 is achieved
when a patient has no relapses, MRI lesions, MS-related brain shrinkage and
disability progression. These data were presented at the 31(st) Congress of the
European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in
Barcelona, Spain.
This follow-up analysis of pooled data from the FREEDOMS and FREEDOMS II core
and extension trials was conducted to assess NEDA-4 each year for seven years in
patients with RMS. The data showed that in the first year, 27.1% of patients on
Gilenya achieved NEDA-4 compared to 9.1% on placebo. Switching from placebo to
Gilenya after year two doubled the proportion of patients achieving NEDA-4
(12.7% to 27.4%) in year three. Of those patients on continuous Gilenya
treatment, 31.2% to 44.8% had NEDA-4-status in each of the years three to
seven[1].
"MS is a chronic debilitating disease and these data are important in showing
the long-term efficacy of Gilenya, and the importance of early treatment to help
improve long-term outcomes for patients," said Vas Narasimhan, Novartis Global
Head of Development. "Better understanding of the course of a person's MS
through assessment of NEDA-4 can help physicians identify the optimal, effective
treatment approach as early as possible for their patients."
A separate follow-up analysis of data from the FREEDOMS and FREEDOMS II trials
also confirmed for the first time that assessment of RMS based on NEDA-4 allowed
physicians to better predict long-term disability and brain shrinkage outcomes
than just assessing relapses, MRI lesions and disability progression. NEDA-4
status over the first year was a significantly better predictor of disability
and brain shrinkage over the subsequent five years, as measured by patients
reaching a stage of severe disability (EDSS >=6: patients require a crutch to
walk approximately 100m) (p<0.0127) or having more than 0.4% mean annual brain
volume loss[2]. These findings support the importance of assessing RMS with
NEDA-4 to enable a more reliable prediction of long-term disease outcomes.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disorder of the central nervous system that
disrupts the normal functioning of the brain, optic nerves and spinal cord
through inflammation and tissue loss[3]. The evolution of MS results in an
increasing loss of both physical and cognitive (e.g. memory) function[4]. This
has a substantial negative impact on the approximately 2.3 million people
worldwide affected by MS[5], a disease that most often begins in early
adulthood[6].
People with MS can be diagnosed with relapsing forms of MS (RMS), which include
relapsing remitting MS and secondary progressive MS[7], or with primary
progressive MS.
The loss of physical and cognitive function in RMS is driven by two types of
damage that result in the loss of neurons and brain tissue - distinct
inflammatory lesions (referred to as focal damage), and more widespread
inflammatory neurodegenerative processes (referred to as diffuse damage). Focal
damage results in the loss of brain tissue and can clinically present as
relapses. Diffuse damage starts early in the disease, often goes unnoticed and
is also associated with loss of brain tissue and accumulated loss of
function[8]-[10].
About Gilenya
Gilenya is the only oral disease-modifying therapy (DMT) to impact the course of
relapsing MS (RMS) with high efficacy across four key measures of disease
activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and
disability progression[11]-[15]. It is approved in the US for the first-line
treatment of relapsing forms of MS in adults[16] 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[17].
Gilenya targets both focal and diffuse central nervous system (CNS) damage. It
prevents cells that cause focal inflammation from reaching the brain (referred
to as 'peripheral' action), but also enters the CNS and reduces the diffuse
damage by preventing the activation of harmful cells residing in the CNS
(referred to as 'central action')[18]-[20]. It is important to address both
focal and diffuse damage in RMS to effectively impact disease activity and help
preserve an individual's functions[4].
Gilenya has been used to treat approximately 125,000 patients in both clinical
trials and the post-marketing setting, with more than 240,000 years of patient
experience. The overall benefit risk profile of Gilenya remains positive[20].
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 and
chronic inflammatory demyelinating polyneuropathy (CIDP). 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, currently in phase III clinical
development and being investigated as an oral therapy for SPMS. Novartis is also
exploring the IL-17 pathway in MS with CJM112.
Novartis also recently announced an agreement to acquire all remaining rights to
GlaxoSmithKline's Ofatumumab, a fully human monoclonal antibody in development
for RRMS. Ofatumumab targets CD20, and is ready to begin phase III pivotal
studies. This agreement is subject to customary closing requirements and
approval by the US Federal Trade Commission.
Additionally, in the US the Sandoz Division of Novartis markets Glatopa(TM), 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 "long-term," "can," "predict," "prediction," "investigational,"
"development," "being investigated," "exploring," "ready," or similar terms, or
by express or implied discussions regarding potential new indications or
labeling for Gilenya, potential future marketing approvals for compounds in
development, or regarding potential future revenues from such products or from
Extavia. 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 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 any compounds in development will be
submitted or approved for sale in any market, or at any particular time.
Neither can there be any guarantee that any of these products, including
Extavia, will be commercially successful in the future. In particular,
management's expectations regarding such products 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 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 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
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.
*Copaxone(®) is a registered trademark of Teva Pharmaceutical Industries Ltd.
References
[1] Cree BAC et al. Long-term effects of fingolimod on NEDA by year of
treatment. Poster presented at: 31(st) ECTRIMS Annual Congress; October 7 -
10, 2015; Barcelona, Spain. Poster Session 1; P627.
[2] Kappos L et al. Predictive value of NEDA for disease outcomes over 6 years
in patients with RRMS. Presented at: 31(st) ECTRIMS Annual Congress; October 7 -
10, 2015; Barcelona, Spain. Parallel Session 5 Personalised therapy; Abstract
570.
[3] http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed October 2015.
[4] http://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms. Accessed
October 2015.
[5] http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf. Accessed
October 2015.
[6] http://www.emsp.org/about-ms/. Accessed October 2015.
[7] http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
15/03/WC500185161.pdf. Accessed October 2015.
[8] Filippi M et al. Association between pathological and MRI findings in
multiple sclerosis. Lancet Neurol. 2012 Apr;11(4):349-60.
[9] Kutzelnigg A et al. Cortical demyelination and diffuse white matter injury
in multiple sclerosis. Brain. 2005 Nov;128(Pt 11):2705-12.
[10] Sormani MP, Arnold DL & De Stefano N. Treatment effect on brain atrophy
correlates with treatment effect on disability in multiple sclerosis. Ann
Neurol. 2014 Jan;75(1):43-9.
[11] Cohen JA et al.; for TRANSFORMS Study Group. Oral fingolimod or
intramuscular interferon for relapsing multiple sclerosis. N Engl J Med.
2010; 362(5):402-415.
[12] Kappos L et al.; for FREEDOMS Study Group. A placebo-controlled trial of
oral fingolimod in relapsing multiple sclerosis.
[13] 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.
[14] 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.
[15] Chin PS et al. Early effect of fingolimod on clinical and MRI related
outcomes in relapsing multiple sclerosis. Poster presented at: 28th Congress of
the European Committee for Treatment and Research in Multiple Sclerosis; October
10-13, 2012; Lyon, France. Abstract P459.
[16] http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008mg.pdf.
Accessed October 2015.
[17] http://ec.europa.eu/health/documents/community-register/html/h677.htm.
Accessed October 2015.
[18] 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.
[19] Chun J & Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in
Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[20] Data on file. Novartis Pharmaceuticals.
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Datum: 08.10.2015 - 07:15 Uhr
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