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Published on 20 March 2013

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Unmet medical need of multiple sclerosis

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New data will be presented at the 65th annual meeting of the American Academy of Neurology (AAN) that show continued innovation within the Novartis Multiple Sclerosis (MS) portfolio.[1]
Growing clinical trial and real-world experience with Gilenya® (fingolimod), the first once-daily oral therapy approved to treat people with relapsing MS (RMS), will be highlighted.[2-7] Updates on studies of Gilenya in people with primary-progressive MS (PPMS)[8] and the investigational agent BAF312 (siponimod) in people with secondary-progressive MS (SPMS) will also be communicated.[9]
“Novartis is pleased to present new data that underscore Gilenya’s pioneering role in the treatment of MS,” said Dr. Timothy Wright, Global Head Development, Novartis Pharmaceuticals AG. “These results, as well as updates on our investigational MS compound BAF312 (siponimod) show that we are making real progress in our commitment to address unmet medical need in MS and to provide a treatment at every stage of the disease.”
Data from three large Phase III studies will highlight the efficacy of Gilenya in reducing the rate of brain volume loss,[2] the best characterised magnetic resonance imaging (MRI) predictor of long-term disability. There will also be a presentation on the INFORMS study, which is evaluating Gilenya in patients with PPMS.[8] This form of MS affects about 10% of people with MS and follows a steady course of worsening neurologic function for which there are no approved disease modifying treatments.[12]
Additional data will showcase Gilenya’s high efficacy and well characterised and manageable safety profile.[4,10,11] Latest information shows that the growing real-world and clinical trial experience base for Gilenya now encompasses more than 50,000 patients and 60,000 patient years of exposure worldwide.[13]
New details will be provided on the design of a Phase III study evaluating the efficacy, safety and tolerability of BAF312 (siponimod) in patients with SPMS, which is a sub-type of MS where there are limited treatment options.[9] The vast majority (85%) of people with relapsing-remitting MS will transition to SPMS; 50% within 10 years of disease onset and 90% within 25 years.[14]
During the AAN congress, Novartis will present a Corporate Therapeutic Update, The Gilenya Experience: A Focus on the Patient in Clinical Practice, on Tuesday 19 March at 19:00 – 22:00 PDT at the San Diego Marriott Marquis. Novartis will also host a Patient Advocacy Forum.
Additionally, to support the exchange of educational information within the MS community, the Novartis exhibit at the congress will showcase an expanded Gilenya online and social media platform including the new Gilenya Facebook and GilenyaGo Twitter accounts, YouTube channel, and Gilenya.com mobile site.
Novartis MS portfolio highlights at AAN include:
Gilenya (fingolimod) in relapsing-remitting MS
  • Fingolimod – effect on brain atrophy and clinical/MRI correlations in three Phase III studies – TRANSFORMS, FREEDOMS and FREEDOMS II. Platform presentation, S51.006 Cohen: 21 March, 15:15 hrs. PDT.
  • Fingolimod reduces annualized relapse rate in patients with relapsing-remitting multiple sclerosis: FREEDOMS II study subgroup analysis. Poster P07.102, Goodin: 21 March, 14:00 hrs. PDT.
  • Long-term safety of fingolimod in patients with relapsing-remitting multiple sclerosis. Results from Phase III FREEDOMS extension study. Poster P01.165, Vollmer: 18 March, 14:00 hrs. PDT.
  • Effect of switching from intramuscular interferon b-1a to fingolimod on time to relapse in patients with relapsing-remitting multiple sclerosis enrolled in a 1-year extension of TRANSFORMS. Poster P07.107, Meng: 21 March, 14:00 hrs. PDT.
  • Effects of fingolimod on disability progression in patients with disability as measured by EDSS at baseline: post-hoc analyses of FREEDOMS I and II. Poster P04.128, Bergvall: 20 March, 07:30 hrs. PDT.
  •  Fingolimod observational studies program in patients with relapsing-remitting multiple sclerosis: Study designs. Poster P07.100, Butzkueven: 21 March, 14:00 hrs. PDT.
Gilenya (fingolimod) in primary progressive MS
  •  Study design and baseline characteristics of the INFORMS study: Fingolimod in patients with primary progressive multiple sclerosis. Poster P07.116, Miller: 21 March, 14:00 hrs. PDT.
BAF312 (siponimod) in secondary-progressive MS
  • Siponimod (BAF312) for the treatment of secondary-progressive multiple sclerosis: design of the Phase III EXPAND trial. Poster P07.126, Kappos: 21 March, 14:00 hrs. PDT.
In addition to marketed products Gilenya and Extavia® (interferon beta-1b for subcutaneous injection) the Novartis MS portfolio includes investigational compounds BAF312 (siponimod), and AIN457 (secukinumab), a fully human monoclonal antibody inhibiting interleukin-17A (IL-17A), a key pro-inflammatory cytokine.
References:
  1. American Academy of Neurology. 2013 AAN annual meeting. http://www.aan.com/go/am13. Last accessed 30 January 2013.
  2. 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.
  3. 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.
  4. 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.
  5. Meng X, et al. Effect of switching from intramuscular interferon b-1a to fingolimod on time to relapse in patients with relapsing-remitting multiple sclerosis enrolled in a 1-year extension of TRANSFORMS. Abstract presented at AAN, San Diego, March 2013.
  6. Bergvall N, et al. Effects of fingolimod on disability progression in patients with disability as measured by EDSS at baseline: Post-hoc analyses of FREEDOMS I and II. Abstract presented at AAN, San Diego, March 2013.
  7. Butzkueven H, et al. Fingolimod observational studies program in patients with relapsing-remitting multiple sclerosis: Study designs. Abstract presented at AAN, San Diego, March 2013.
  8. Miller D, et al. Study design and baseline characteristics of the INFORMS study: Fingolimod in patients with primary progressive multiple sclerosis. Abstract presented at AAN, San Diego, March 2013.
  9. Kappos L, et al. Siponimod (BAF312) for the treatment of secondary-progressive multiple sclerosis: design of the Phase III EXPAND trial. Abstract presented at AAN, San Diego, March 2013.
  10. 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.
  11. 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.
  12. National Multiple Sclerosis Society. http://www.nationalmssociety.org/about-multiple-sclerosis/progressive-ms/primary-progressive-ms/index.aspx. Last accessed 30 January 2013.
  13. Data on file. Novartis Pharma AG.
  14. National Multiple Sclerosis Society. http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-ms/secondary-progressive-ms-spms/index.aspx. Last accessed 25 February 2013.


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