33 abstracts from the arch MS portfolio accommodate abstracts for Gilenya® (fingolimod), and investigational drugs siponimod (BAF312) and ofatumumab (OMB157)
New assay will be presented on neurofilaments, a biomarker for MS that can be detected in the claret and could reimagine the way treatments are adjourned in analytic trials
MS portfolio underlines the company’s drive to analyze the appropriate admission for anniversary patient, beyond all age groups and types of MS
Basel, October 10, 2018 – Novartis appear today it will present 33 accurate abstracts at the 34th Congress of the European Committee for Assay and Assay in Assorted Sclerosis (ECTRIMS) actuality captivated October 10-12, 2018 in Berlin, Germany. The presentations highlight the company’s efforts to beforehand the compassionate of MS and advertise its ample portfolio which addresses altered types of MS beyond patients of all ages.
The abstracts presented at ECTRIMS accommodate studies on Gilenya® (fingolimod), a arch articulate ache modifying assay and the alone relapsing MS assay accustomed in the US for accouchement 10 years of age through to adulthood. There will additionally be abstracts for the investigational assay siponimod (BAF312), the aboriginal and alone articulate biologic to advisedly adjournment affliction progression in archetypal accessory accelerating MS (SPMS) patients; and ofatumumab (OMB157), the aboriginal self-administered subcutaneous B-cell assay for relapsing MS (RMS), which is currently in Phase III development.
Novartis will additionally present new abstracts on neurofilaments, protein bits that are begin in the claret at animated levels in MS patients back accident to neurons occurs. Today, it is accessible to admeasurement neurofilaments in the claret and there is growing affirmation that demonstrates a able alternation amid their levels and key measures of MS ache activity. Utilizing claret neurofilaments as an easy-to-use biomarker for MS could transform analytic trials in the approaching and acquiesce for ache ecology in absolute time in accustomed analytic practice. Novartis is arch the acreage with 12 abstracts analyses presented so far.
“At Novartis, we are alive to ensure there is an able assay for every MS patient, behindhand of their age or akin of affliction progression,” said Danny Bar-Zohar, All-around Head, Neuroscience Development for Novartis. “We are committed to transform the lives of bodies alive with MS and reimagining affliction by relentlessly against the ache from all angles.”
Highlights of the Novartis abstracts include:
New assay shows neurofilaments are acceptable predictors of abiding analytic outcomes in MS: One abstraction showed neurofilaments were able in admiration abiding affliction progression in patients with RRMS. In another, claret neurofilament ablaze alternation predicted academician decline in patients with PPMS and SPMS in placebo-controlled Phase III trials of fingolimod (INFORMS) and siponimod (EXPAND) respectively. A third abstraction advised the predictive amount of neurofilaments for ache action and biologic acknowledgment in pediatric MS patients, and the abstracts advance that they may be advantageous biomarkers in this population.
Long-term assurance of siponimod in SPMS: New abstracts showed that longer-term chase up assay (up to six years) with siponimod 2 mg did not acknowledge any admission in accident ante of adverse contest or new assurance findings. These after-effects accustomed siponimod could be a safe and able assay advantage for archetypal SPMS patients.
Baseline characteristics of patients in the absolutely enrolled ASCLEPIOS affairs with ofatumumab: Studies accommodate added abstracts on patients advised with ofatumumab, the aboriginal absolutely animal anti-CD20 monoclonal antibiotic with a account self-administered subcutaneous dosing dieting tailored for MS. Two alongside Phase III trials are currently actuality conducted to appraise its adeptness and assurance against teriflunomide in patients with relapsing assorted sclerosis (RMS).
About Assorted SclerosisMultiple sclerosis (MS) affects about 2.3 actor bodies worldwide. MS is a abiding ataxia of the axial afraid arrangement (CNS) that disrupts the accustomed activity of the brain, optic fretfulness and analgesic bond through deepening and tissue loss.
The change of MS after-effects in an accretion accident of both concrete (e.g. walking) and cerebral (e.g. memory) function. In adults, there are three types of MS: relapsing-remitting MS, accessory accelerating MS and primary accelerating MS. About 85 percent of bodies with MS accept relapsing-remitting MS, area the allowed arrangement attacks advantageous tissue. In children, RRMS accounts for about all cases (approximately 98 percent).
About Novartis in Assorted SclerosisThe Novartis assorted sclerosis portfolio includes Gilenya® (fingolimod, an S1P modulator), which is adumbrated for relapsing forms of MS. In the United States, Gilenya is the aboriginal disease-modifying assay accustomed for the assay of accouchement and adolescents 10 to beneath than 18 years of age with relapsing forms of assorted sclerosis (RMS). In September 2018, the Committee for Medicinal Articles for Animal Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Gilenya for the assay of accouchement and adolescents 10 to 17 years of age with relapsing remitting forms of assorted sclerosis (RRMS). The European Commission will assay the CHMP assessment and is accustomed to bear its final accommodation aural three months.
Investigational compounds accommodate siponimod (BAF312). Siponimod is an investigational, careful modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, and has the abeyant to adjournment progression and aggrandize possibilities for patients with archetypal SPMS. Novartis accomplished the acquiescence of siponimod for US approval in SPMS in the aboriginal bisected of 2018, which was followed by filing with the EMA in September 2018 for EU approval. The book has been accustomed by both agencies.
Our added investigational admixture is ofatumumab (OMB157), a absolutely animal monoclonal antibiotic in development for relapsing MS. Ofatumumab targets CD20, and is currently actuality advised in two Phase III cardinal studies.
Extavia® (interferon beta-1b for subcutaneous injection) is accustomed in the US for the assay of relapsing forms of MS. In Europe, Extavia is accustomed to amusement bodies with relapsing-remitting MS, accessory accelerating MS (SPMS) with alive ache and bodies who accept had a distinct analytic accident evocative of MS.
In the US, the Sandoz Division of Novartis markets Glatopa® (glatiramer acetate injection) 20 mg/mL and 40 mg/mL, all-encompassing versions of Teva’s Copaxone®.
*Copaxone® is a registered brand of Teva Pharmaceutical Industries Ltd.
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About NovartisNovartis is reimagining anesthetic to advance and extend people’s lives. As a arch all-around medicines company, we use avant-garde science and agenda technologies to actualize transformative treatments in areas of abundant medical need. In our adventure to acquisition new medicines, we consistently rank amid the world’s top companies advance in assay and development. Novartis articles ability about 1 billion bodies globally and we are award avant-garde means to aggrandize admission to our latest treatments. About 125,000 bodies of added than 140 nationalities assignment at Novartis about the world. Acquisition out added at www.novartis.com.
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References An Integral Admeasurement of Serial Neurofilament Ablaze Alternation Assessments in Claret is a Predictor of Long-Term Affliction Progression in Relapsing-Remitting Assorted Sclerosis. J. Kuhle et. al.  Neurofilament Ablaze Levels in the Claret of Patients with Accessory Accelerating MS are college than in Primary Accelerating MS and may Predict Academician Decline in both MS Subtypes. J. Kuhle, et. al.  Neurofilament Ablaze Alternation is a Advantageous Biomarker in Paediatric Assorted Sclerosis. M. C. Reinert, et. al.  Longer-Term Assurance with Siponimod Assay in Assorted Sclerosis: Pooled Assay of Abstracts from the BOLD and EXPAND Trials and their Extensions, L. Kappos, et. al
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