A key treatment goal for patients with MS is 'no evidence of disease activity' (NEDA), currently defined as no relapses, MRI lesions and disability progression
Including MS-related brain shrinkage (brain volume loss) as a fourth key measure captures underlying damage that begins early in MS and is associated with loss of function
The likelihood of achieving NEDA across four key measures was more than four-times greater in patients treated with Gilenya compared to placebo
The digital press release with multimedia content can be accessed here:
Basel, Sept 12, 2014- Novartis announced today new analyses presented at the Joint ACTRIMS-ECTRIMS Meeting in Boston, USA, which confirmed the high efficacy of Gilenya® (fingolimod) in achieving 'no evidence of disease activity' (NEDA) in people with relapsing-remitting multiple sclerosis (RRMS) across four key disease measures - relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression. Specifically, patients taking Gilenya had a more than four-times greater likelihood of achieving NEDA across these four key measures (odds ratio 4.41; 95% CI 3.03-6.42; p<0.0001).
NEDA is currently defined as having no relapses, MRI lesions and disability progression. These new analyses from the phase III FREEDOMS and FREEDOMS II trials reinforce the value of including brain shrinkage to the definition of NEDA. The inclusion of brain shrinkage into the NEDA definition would allow physicians to obtain a more complete assessment of a patient's disease, including the underlying damage in MS.
"Adopting this more comprehensive definition of NEDA, which includes brain shrinkage, allows for a more detailed assessment of disease activity in patients with MS," said Vasant Narasimhan, Global Head of Development at Novartis Pharmaceuticals. "The data highlight the proven high efficacy of Gilenya, based on this new improved definition, across four key measures of MS."
The loss of physical and cognitive function in MS 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). Distinct inflammatory lesions result in the loss of brain tissue and can clinically present as relapses. Widespread inflammatory damage starts early in the disease, often goes unnoticed and is also associated with loss of brain tissue and accumulated loss of function-. Redefining NEDA to include four key measures of MS addresses both types of damage, giving physicians a more comprehensive and balanced assessment of MS and treatment effects.
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. The evolution of MS results in an increasing loss of both physical (e.g. walking) and cognitive (e.g. memory) function. This has a substantial negative impact on the approximately 2.3 million people worldwide affected by MS, a disease that begins in early adulthood, most often between the ages of 20 and 40.
About Gilenya Gilenya is the only oral disease-modifying therapy (DMT) to impact the course of relapsing-remitting MS (RRMS) with high efficacy across four key measures of disease activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and disability progression-.
Gilenya targets both focal and diffuse 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')-. It is important to address both focal and diffuse damage in RRMS to effectively impact disease activity and help preserve an individual's physical (e.g. walking) and cognitive (e.g. memory) function.
Gilenya has been used to treat more than 100,000 patients in a clinical trial and post-marketing setting over ten years and has a well-established safety profile.
About Novartis in Multiple Sclerosis Novartis is committed to the research and development of new treatment options to offer the right treatment to the right patient at the right time, to meet patients' needs at every stage of disease with innovative and targeted drugs.
In addition to its ongoing development program for Gilenya in primary progressive MS (PPMS), pediatric MS and chronic inflammatory demyelinating polyneuropathy (CIDP), the Novartis MS portfolio includes Extavia® (interferon beta-1b for subcutaneous injection). Investigational compounds include BAF312 (siponimod), currently in Phase III clinical development and being developed as the first oral therapy for secondary progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "committed," "can," "ongoing," "investigational," "being developed," "exploring," or similar terms, or by express or implied discussions regarding potential future indications or labeling for Gilenya, potential future marketing submissions or approvals for the other investigational compounds in the Novartis MS portfolio, or regarding potential future revenues from any or all of the products and investigational compounds in the Novartis MS portfolio, including Gilenya. 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 of the investigational compounds in the Novartis MS portfolio will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that any of the products and investigational compounds in the Novartis MS portfolio will be commercially successful in the future. In particular, management's expectations regarding these 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, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 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 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.
References  Kappos L et al. Inclusion of brain volume loss in a revised measure of multiple sclerosis disease-activity freedom: the effect of fingolimod. Abstract presented at: 2014 Joint ACTRIMS-ECTRIMS Meeting; September 10-13, 2014; Boston, Massachusetts. Abstract 1570. Free communication FC1.5.  Filippi M et al. Association between pathological and MRI findings in multiple sclerosis. Lancet Neurol. 2012 Apr;11(4):349-60.  Kutzelnigg A et al. Cortical demyelination and diffuse white matter injury in multiple sclerosis. Brain. 2005 Nov;128(Pt 11):2705-12.  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.  http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001747/. Accessed August 2014.  http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/symptoms/index.aspx. Accessed August 2014.  http://www.msif.org/includes/documents/cm_docs/2013/m/msif-atlas-of-ms-2013-report.pdf?f=1. Accessed August 2014.  http://emsp.org/multiple-sclerosis/ms-fact-sheet. Accessed August 2014.  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.  Kappos L et al.; for FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.  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.  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.  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.  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.  Chun J & Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.  Data on file. Novartis Pharmaceuticals.