RRMS

The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…

Vumerity (diroximel fumarate) carries fewer and less severe gastrointestinal side effects compared to Tecfidera (dimethyl fumarate), new data from a Phase 3 trial directly comparing the GI tolerability of these two relapsing-remitting multiple sclerosis (RRMS) treatments show. These results were presented at the 27th Annual Meeting of the European Charcot Foundation,…

A DNA analysis to identify changes in the gut microbiome in people newly diagnosed with multiple sclerosis — who have yet to begin using disease-modifying therapies — showed that all, regardless of ethnic background, have an abundance of the bacteria group Clostridia compared to people…

African-Americans and Hispanics with relapsing-remitting multiple sclerosis (RRMS) have higher blood levels of plasmablasts, a type of inflammatory immune cell that produces antibodies, than do Caucasians with this disease, a study found. The study “Black African and Latino/a identity correlates with increased plasmablasts in MS” was published in the journal…

Pregnancy does not lead to long-term changes in the disease course of multiple sclerosis (MS), new research suggests. This work, which emphasizes the importance of careful data analysis, supports studies disputing previous beliefs that pregnancy worsened or lessened the long-term disease course of MS. The findings were presented by Mar Tintore,…

The National Multiple Sclerosis Society has criticized Biogen for the $88,000 yearly list price it placed on Vumerity (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases with Tecfidera (dimethyl fumarate), Biogen’s similar oral DMT for…

With the help of 7 Tesla magnetic resonance imaging (MRI), investigators discovered that leptomeningeal enhancement — a radiographic finding indicative of brain inflammation — is more common than previously thought in people with relapsing-remitting multiple sclerosis (RRMS), and is tied to lesions in specific regions of the brain.

Long-term treatment with interferon beta (IFN-beta) corrects the defective immune balance characteristic of people with relapsing-remitting multiple sclerosis (RRMS), a study has found. The study also identified more than 200 genes with significantly different activity between complete and partial responders to IFN-beta treatment, which could be used to identify which…

EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs I’m highlighting this report because, like several Europe-based doctors I know, I think that this decision is an overreaction. While there have been serious complications associated with Lemtrada (alemtuzumab), forcing a patient to…

People with relapsing-remitting multiple sclerosis (RRMS) have poorer neurite density — a measure that relates to the amount of nerve cell projections, including axons and dendrites involved in nerve-to-nerve communication — in the brain and spinal cord than do those without this disease, a study shows. This measure, especially…

Pharmascience recently launched pms-Fingolimod, a generic version of Novartis’ Gilenya (fingolimod), to treat adults with relapsing-remitting multiple sclerosis (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. Generic medicines are chemically identical to the original branded therapy, but carry a…

Employed individuals with relapsing-remitting multiple sclerosis (RRMS) have lower work productivity, reduced health-related quality of life, and use more healthcare resources than individuals who do not have multiple sclerosis (MS), a new study shows. The study, “Burden of relapsing-remitting multiple sclerosis on workers in the US: a cross-sectional…

Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…

Vumerity Approved in US as Treatment for RRMS and Active SPMS By my count, Vumerity is the 18th disease-modifying therapy (DMT) that the U.S. Food and Drug Administration (FDA) has approved for multiple sclerosis (MS). It’s one of very few approved for secondary progressive MS (SPMS). I find…

Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version of Novartis’ Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system called Health Canada. Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…

Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…

Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…

Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…

With more high-efficacy therapies becoming available, is it now inappropriate to prescribe older injectables — interferon beta and glatiramer acetate — to people with active relapsing multiple sclerosis (MS)? This question was at the core of what was called a “burning debate” at this year’s European Committee…

The levels of the inflammatory molecule interleukin-22 (IL-22) may be used as a potential biomarker to evaluate disease severity and the effectiveness of treatments in patients with relapsing-remitting multiple sclerosis (RRMS), a new study shows. The study, “Impact of interferon β-1b, interferon β-1a and fingolimod therapies on serum…

Ofatumumab, an investigational B-cell therapy being developed by Novartis, demonstrated encouraging results in lowering relapse rates and active brain lesions in people with relapsing multiple sclerosis (MS) enrolled in the ASCLEPIOS trials. For Stephen L. Hauser, MD, an investigator in the ASCLEPIOS trials, these results represent a…

Immunic Therapeutics announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapy for relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule. The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210…

Prescriptions of two multiple sclerosis (MS) treatments —  Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) — have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…

People with relapsing-remitting multiple sclerosis (RRMS) who don’t use disease-modifying therapies (DMTs) are more likely to have been misdiagnosed previously, and to have poorer relationships with their healthcare providers, the results of a new survey suggest. The survey, titled “Multiple Sclerosis In America 2019,” was conducted by …

Careful profiling of inflammatory markers in cerebrospinal fluid (CSF) of multiple sclerosis patients, coupled with standard exams and scans, helps in understanding disease evolution and treatment response, a case report suggests. It followed a relapsing-remitting multiple sclerosis (RRMS) patient whose inflammatory markers in the CSF remained high over time, and…

EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinib in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is…

The most recent data continue to support Mayzent‘s (siponimod) benefits and provide more insights on how this therapy can make a difference for those with relapsing forms of multiple sclerosis (MS) — in particular, data showing the therapy lowers the risk of becoming wheelchair-dependent. New results from…

Celgene‘s oral ozanimod, if approved, could be a first-line oral treatment option for people with relapsing multiple sclerosis (MS), and one with relatively minor side effects. Recent results from the Phase 3 trials RADIANCE (NCT02047734) and…