The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…
RRMS
Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, Tecfidera (dimethyl fumarate) has emerged as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). While two separate clinical trials demonstrated Tecfidera’s ability to significantly reduce both the rate of relapse…
Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients. The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the…
Fingolimod (Gilenya) Seen to Promote Peripheral Nerve Regeneration in Mice, Aiding Remyelination
Fingolimod (Gilenya), a drug approved for patients with relapsing-remitting multiple sclerosis (RRMS) to prevent neuroinflammation, may also help these patients by directly enhancing nerve regeneration and increasing myelination in a way that is partly independent of its anti-inflammatory properties. The study reporting this finding, “Fingolimod promotes peripheral nerve regeneration…
Genmab announced plans to soon begin a Phase 3 clinical trial program assessing the subcutaneous formulation of ofatumumab as a potential treatment for relapsing multiple sclerosis (MS). The company, working in collaboration with its partner Novartis, will begin enrolling patients in September in trials that will evaluate the efficacy and safety of ofatumumab compared…
GeNeuro, a biopharmaceutical company that focuses on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced that the first patients with relapsing-remitting multiple sclerosis (RRMS) are under treatment with the company’s leading drug, GNbAC1, in a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…
Arrien Pharmaceuticals has initiated Phase 1 clinical trials of their first agent, ARN-6039, a molecule that targets a specific subset of immune cells called T helper 17 (Th17), for the potential treatment of patients with relapsing, remitting, and progressive multiple sclerosis (MS). A growing body of evidence has suggested a…
#CMSC16 – Fingolimod (Gilenya) Offers Consistent Health Benefits in Relapsing-Remitting MS Patients
Researchers at the Swedish Neuroscience Institute in Washington and Novartis Pharma revealed that Gilenya (fingolimod) induced a consistent and significant reduction in disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). The results were recently presented at the June 1-4 Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual…
MS does not remit and the out dated term causes many people to delay taking medication, says Dr Patricia Coyle, Founder and Director of Stony Brook’s MS Comprehensive Care Center. Dr. Patricia Coyle. Last week, at the CMSC Annual Meeting in Maryland, during a live-streamed presentation covered by Multiple Sclerosis News Today, she…
Results from a Phase 2 clinical trial showed that five-year clinical outcomes of patients with highly active relapsing-remitting multiple sclerosis (RRMS) are significantly improved when patients are treated with high-dose immunosuppressive therapy combined with autologous hematopoietic cell transplantation. The study, “Five-Year Outcomes of Halt-MS: High- Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell…
Results from the STRIVE study support the safety of natalizumab (Tysabri) as a therapy for multiple sclerosis (MS) patients. The study, “Natalizumab in Anti-JC Virus Seronegative Patients with Early Relapsing-Remitting Multiple Sclerosis: Interim Results from the STRIVE Study,” was recently presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis…
#CMSC16 – Delayed-release Dimethyl Fumarate Benefits Newly Diagnosed MS Patients, According to Study
Newly diagnosed patients with relapsing-remitting multiple sclerosis (RRMS) show significant improvements when treated with delayed-release dimethyl fumarate (DMF), especially in terms of reduction in confirmed disability progression. The study, “Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Multiple Sclerosis Using a Composite Measure of Disability,” was recently presented at the…
#CMSC16 – RRMS Patients on Alemtuzumab (Lemtrada) Show Slowed Disability Progression Over Five Years
A study of relapsing-remitting multiple sclerosis (RRMS) patients who had one or more relapses on earlier treatment, showed that alemtuzumab (Lemtrada) improved disability progression over five years, even though most patients received treatment only during the first two years. The study showed that alemtuzumab is a viable option for long-term…
Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to be used in people with elapsing-remitting multiple sclerosis (RRMS).
Researchers detected the expression of the gene ANKRD55 in immune cells, a gene that has been previously linked to multiple sclerosis (MS) in mice models of the disease. The results suggest a potential role of ANKRD55 in MS pathogenesis. The study, “Novel Insights into the Multiple Sclerosis Risk Gene ANKRD55,”…
The Russian Ministry of Health recently granted Marketing Authorization (ЛП-003567) to R-Pharm JSC for the development of “Glatirat” (Glatiramer acetate), a drug intended for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome. According to a press release, the registration of “Glatirat” was based…
Sanofi Genzyme recently launched vs.MS, a global initiative to raise awareness of the often unspoken physical and emotional burden of relapsing multiple sclerosis (RMS) on people living with the disease and their care partners. On World MS Day yesterday, the company called on the MS community to learn more about the…
Yissum Research Development Company, an arm of Hebrew University of Jerusalem, has entered into an agreement with Aurum Ventures MKI to develop a diagnostic blood test for relapsing-remitting multiple sclerosis (RRMS) and a range of other diseases, which uses differences in DNA from dying cells found in the blood of sick individuals.
Researchers at the University of Heidelberg, Germany, recently showed that peripheral blood cells loaded with a drug that resembles the myelin protein are able to inhibit harmful immune responses and prevent relapses in a mouse model of relapsing-remitting multiple sclerosis (MS). The findings were described in the study “…
A case report of a woman with relapsing-remitting multiple sclerosis (MS), who developed progressive multifocal leukoencephalopathy (PML) after natalizumab therapy, found that the immune-boosting molecule interleukin-2 (IL-2) might be a viable therapeutic option to fight this life-threatening complication although further study is needed. The case report, “Use of interleukin-2 for…
TG Therapeutics recently announced the opening of a new clinical trial evaluating TG-1101, its glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS). The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients…
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently recommended marketing authorization to Zinbryta (daclizumab) for the treatment of patients with relapsing multiple sclerosis (RMS). Zinbryta (daclizumab HYP) is a humanized monoclonal antibody that is injected every four weeks, and being developed by…
New data presented by Biogen and AbbVie at the recent 68th annual meeting of the American Academy of Neurology (AAN) showed that Zinbryta (daclizumab high-yield process) improved cognitive outcome measures in patients with relapsing forms of multiple sclerosis (RMS). Additional results — from post-hoc analyses of clinical trials — also offer a better…
Mabthera (rituximab), a widely approved drug for treating lymphoma and/or rheumatoid arthritis, is highly effective in treating multiple sclerosis (MS), researchers reported in an observational study in Sweden, where Mabthera is increasingly being used outside of its approved indications to treat relapsing-remitting MS patients. The study, published in the journal…
Biogen reported new data describing the effectiveness of Tecfidera (dimethyl fumarate) in newly diagnosed relapsing-remitting multiple sclerosis (RRMS) patients in a recent presentation at the 68th annual meeting of the American Academy of Neurology (AAN). The conference, taking place in Vancouver, Canada, runs through April 21. Tecfidera is an…
Sanofi Genzyme is presenting promising data regarding brain volume and retinal nerve fibers in multiple sclerosis (MS) patients — drawn from an ongoing extension study into the disease-modifying drug alemtuzumab (Lemtrada) — at the 2016 American Academy of Neurology (AAN) Annual Meeting taking place in Vancouver, Canada, through April…
A case report of a woman with relapsing-remitting multiple sclerosis (RRMS) who developed shingles while being treated with dimethyl fumarate (Tecfidera) has raised questions of whether the drug reactivates the varicella-zoster virus. The study, “Disseminated zoster with paresis in a multiple sclerosis patient treated with dimethyl fumarate,“ was published in…
Scientists at the Pediatric MS Center at NYU Langone, New York, reported that U.S. adolescents with multiple sclerosis (MS) receiving interferon-beta 1a therapy had a higher body mass index (BMI), more relapses, and were managed differently compared to patients of similar age in seven other countries. The study, “Subcutaneous…
RedHill Biopharma, Ltd. recently announced promising interim results from its ongoing CEASE-MS Phase 2a clinical trial evaluating the safety and efficacy of a fixed dose of RHB-104 as an add-on therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). RHB-104 consists of an oral capsule formulation of an antibiotic combination therapy —…
A major dilemma facing clinicians is whether to continue treatment with disease-modifying drugs, effective in relapsing-remitting multiple sclerosis (RRMS), as the disease progresses to secondary progressive MS (SPMS). In SPMS, these treatments seem to lose their benefits and — as they are often associated with severe side effects and high costs — clinicians…
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