RRMS

The U.S. Food and Drug Administration has approved a supplemental biologics license application for two Bayer products that help multiple sclerosis patients keep track of their injections of Betaseron (interferon beta-1b). The products are the myBETAapp and the Betaconnect Navigator software. A biologics license application is a request for permission to market…

Patients with relapsing-remitting multiple sclerosis (RRMS) regain part of their balance control after a single training session of ball-throwing exercises, finds a study supported by the National Multiple Sclerosis Society. Researchers presented their study, “A Single-Session Training of Ball Throwing Exercise Improves Balance Control in Individuals with Multiple Sclerosis,” at…

A real-world medical-facilities setting has confirmed clinical trial findings that Gilenya (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published in Plos One. Gilenya, developed by Novartis Pharmaceuticals, was the first oral disease-modifying therapy to obtain U.S. and European approval. The Food and Drug Administration and European Medicines Agency authorized…

A large-scale study revealed potential adverse reactions to beta-interferon (IFN-β) therapy, one of the most common treatments used for relapsing-remitting multiple sclerosis (RRMS). According to the study published in the journal Neurology, patients have an increased risk of stroke, migraine, depression, and of developing abnormalities in the blood. In…

Laquinimod failed to meet its primary Phase 3 clinical trial objective of slowing the progression of relapsing-remitting multiple sclerosis (RRMS) after three months, according to its developers, Teva Pharmaceutical Industries and Active Biotech. That has prompted the partners to abandon their quest to use the therapy to treat RRMS. Laquinimod…

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates. The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston,…

Many decisions to stop taking the multiple sclerosis treatment Tysabri (natalizumab) appear to be based largely on subjective factors such as patients’ or physicians’ view of the risk, rather than objective assessments of the risk, a study indicates. Tysabri is an approved immunotherapy for active relapsing-remitting multiple sclerosis (RRMS). Despite its benefits, there…

The latest results on Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) use in a clinical practice setting suggest that early treatment can improve outcomes in multiple sclerosis (MS) patients. This and other recent data on Tecfidera and Tysabri for the treatment of MS will be presented by Biogen at the…

Teva Pharmaceutical Industries will discuss two of its multiple sclerosis therapies, one that reduces relapses and one that appears to protect nerve structure, at a premier neurology conference in Boston this month. It will also give presentations at the 2017 Annual Meeting of the American Academy of Neurology on therapies…

A 60-year longitudinal multiple sclerosis (MS) study in a Norwegian cohort analyzing life expectancy, survival and mortality concluded that MS patients live shorter lives and have higher mortality than the general population. The report, “Survival and cause of death in multiple sclerosis: a 60-year longitudinal population study,”…

  The United Kingdom’s National Institute for Health and Care Excellence (NICE) last month recommended Zinbryta (daclizumab) to treat relapsing-remitting multiple sclerosis (RRMS) in England and Wales. On April 10, Scotland received Scottish Medicines Consortium (SMC) approval for the National Health Service (NHS) to prescribe Zinbryta as a treatment for RRMS. Zinbryta is…

Alkermes has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera…

People with secondary progressive multiple sclerosis (SPMS) are more likely to feel exhausted and have limited leg function than those without progressive MS as they age, a preliminary study suggests. The findings will be presented at the American Academy of Neurology (AAN) 69th Annual Meeting, set for April 22-28 in Boston.

EMD Soreno has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Reduced brain atrophy rates are associated with lower risk of disability progression…

An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findings were in the study, “Switching from branded to generic glatiramer acetate:…

The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) for Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval for Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and — for a first…

Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…

Data from the CARE-MS II clinical trial showed that Lemtrada (alemtuzumab) can lessen pre-existing disabilities in patients with relapsing-remitting multiple sclerosis (RRMS) who failed to respond adequately to previous disease-modifying therapies, according to a study of the trial’s data. The treatment was evaluated against Rebif (interferon beta-1a) therapy. The study, “Alemtuzumab…

The Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report evaluating the comparative clinical effectiveness and value of disease-modifying therapies (DMTs) for patients with relapsing-remitting and primary-progressive forms of multiple sclerosis (MS). Through Dec. 21, patients, the public, and other stakeholders can access the 82-page report and…

Damaging immune system defects seen in patients with multiple sclerosis (MS) can be repaired using a simple stem cell approach, according to a new study by researchers in China and the U.S. The study, “Umbilical Cord-Derived Mesenchymal Stem Cells Reversed The Suppressive Deficiency Of T Regulatory Cells From Peripheral Blood Of…

Multiple sclerosis (MS) patients with more advanced disease, as evidenced by disability, and those more frequent relapses or aversion to needles are among the groups of people at higher risk of discontinuing Betaferon (interferon beta-1b) treatment, researchers report. These findings may help to alert clinicians to those least likely to adhere to…

RedHill Biopharma recently announced that it has received a Notice of Allowance from the Japan Patent Office for a new patent covering RHB-104 as a potential treatment of multiple sclerosis (MS). Once granted, the patent will be valid until 2032. The European Patent Office also recently approved a patent application for the drug with this…

An indirect comparison of results from randomized clinical trials in relapsing-remitting multiple sclerosis (RRMS) patients suggests that Tysabri (natalizumab) is more effective than Gilenya (fingolimod) at reducing disease activity. The study, “The Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect…

The Multiple Sclerosis (MS) Trust is expressing its disappointment at the recent committee decision of the National Institute for Health and Care Excellence (NICE) to not recommend Zinbryta (daclizumab) be made available as a therapy to MS patients using the public health system in England and Wales. NICE’s preliminary recommendation was based on a review of…

Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…

Novartis recently announced positive results from the ACROSS study, which is assessing the clinical effect of Gilenya (fingolimod) in 10-year disability outcomes in people with relapsing-remitting multiple sclerosis (RRMS). The results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London. The ACROSS study…

GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe. The company also reported on the trial’s design in a poster presentation, “A placebo…

Merck recently presented new efficacy data from its three Phase 3 clinical trials, showing that a relatively short course of treatment with Cladribine tablets led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were given in two oral presentation at the 32nd Congress of the…

Biogen and AbbVie presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, which showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) had no evidence of disease activity (NEDA) compared to those treated with Avonex (interferon beta-1a). The data were given at the recent 32nd Congress of the European…

Positive new data from Phase 3 clinical trials assessing Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigational therapy. The results are being presented at the 32nd Congress of the…