FDA Rejects Under-the-skin Tysabri for Relapsing MS I expect this decision will be a disappointment for those who had hoped to be able to self-administer highly effective Tysabri as a shot rather than an IV infusion. But I switched from Avonex to Tysabri, because after a few years of…
Tysabri
The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a…
MS News That Caught My Eye Last Week: COVID-19 and Flares, Hiding MS Status, Blood Proteins, Tysabri
#AANAM – COVID-19 Often Leads to Flares in MS Patients, Survey Finds I’ve read more than a few social media posts from people with MS who are concerned that the COVID-19 vaccines will cause a flare. National MS Association guidelines say the vaccines may cause a temporary, mild fever…
Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Treatment with Tysabri (natalizumab) can improve mental and social health in people with multiple sclerosis (MS), according to new…
The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remitting multiple sclerosis (RRMS). This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation,…
Off-label treatment with Tysabri (natalizumab) significantly lessens disease activity and reduces the number of relapses per year in patients with pediatric-onset multiple sclerosis (POMS), real-world data from Portugal show. The treatment also was considered safe in this population, in agreement with earlier studies. These findings support the usefulness…
Stories marked #ACTRIMS2021 are by members of the Multiple Sclerosis News Today team, who reported on this annual conference of MS researchers, held virtually this year due to COVID-19. #ACTRIMS2021 – 30 Minutes in Sun Each Day Lowers MS Risk in Children Can it really be this…
Patients with multiple sclerosis (MS) switching from Tysabri (natalizumab) to moderate-efficacy disease-modifying therapies (DMTs) are at a higher risk of showing signs of MS activity and experiencing disability progression than those switching to high-efficacy DMTs, a real-world study found. Based on these findings, the researchers are arguing that,…
Drop in PML With Tysabri Use in Sweden Likely Due to Risk Management Plan I’m JCV-positive, so I’m at risk for PML if I’m being treated with Tysabri. And I was treated with Tysabri for seven years without a problem. That, I believe, is because my neurologist carefully followed…
The number of cases of Tysabri (natalizumab) that are associated with progressive multifocal leukoencephalopathy (PML) — a serious brain infection — in multiple sclerosis (MS) patients living in Sweden fell between 2006 and 2018, a study shows. Notably, the data highlighted that this drop was likely due to…
Age is a main driver of disability in multiple sclerosis (MS) and has a key influence on patients’ therapeutic responses to Tecfidera (dimethyl fumarate) and Tysabri (natalizumab), a study showed. Given those findings, age should be considered in the risk/benefit assessment that’s used in the decision-making process for…
Researchers from the Kessler Foundation will launch a new study investigating the effects of Tysabri (natalizumab) on cognitive fatigue — the type of fatigue that happens after strong mental concentration, such as in problem-solving — in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue, which is very…
Tysabri Affects Immune System Beyond Known MS Target, Study Finds Tysabri (natalizumab) slows multiple sclerosis progression by blocking some immune cells from entering the central nervous system, where they attack the myelin coating of nerves. Yet this study shows that Tysabri may also significantly reduce the number of proteins…
Lower levels of pro-inflammatory immune signaling proteins were found in the blood of people with relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) and were associated with fewer relapses and less disability, a study has found.
Treatment with Tysabri (natalizumab) was more effective than Gilenya (fingolimod) in helping people with relapsing–remitting multiple sclerosis (RRMS) achieve no evidence of disease activity, a head-to-head study suggested. The study, “BEST-MS: A prospective head-to-head comparative study of natalizumab and fingolimod in active relapsing MS,” was…
Phase 3 Trial of Sativex, Cannabis Extract Treatment for MS Spasticity, Opens in US This is a major step toward making a clinically tested, cannabis-based medication available in the U.S. I’ve always thought that medications containing a THC/CBD combination are useful to lessen some MS symptoms, but the lack…
Adults with active relapsing-remitting multiple sclerosis (RRMS) treated with Tysabri (natalizumab) had fewer new and accumulated lesions, and a lower relapse rate than those treated with Gilenya (fingolimod) for 24 weeks, according to…
Tysabri (natalizumab) is superior to other disease-modifying therapies (DMTs) at improving balance and vision, easing bladder problems and sexual dysfunction, and alleviating anxiety in people with multiple sclerosis (MS), according to data from an Australian study. The study’s findings were presented at…
Rituximab is more effective and leads to fewer treatment discontinuations in people with multiple sclerosis (MS) than Gilenya (fingolimod) and Tecfidera (dimethyl fumarate), according to real-world data based on two years of therapy. Rituximab’s effectiveness appeared to be comparable to that of Tysabri (natalizumab), but with fewer…
Order Seen in Motor Skills Affected by MS, With Walking Taking First Hit Read this headline carefully. It reports that walking takes the “first hit,” but that doesn’t mean it’s the first MS symptom people experience. My first symptoms involved vision, fatigue, and hand strength. But true to the…
Tysabri (natalizumab) is effective at reducing the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS) and is rarely associated with poor clinical outcomes, a real-life and multiyear observational study reports. The study, “Long-term effect of natalizumab in patients with RRMS: TYSTEN…
Treatment with Tysabri (natalizumab) can lessen disability in people with relapsing-remitting multiple sclerosis (RRMS), a large and real-world study found, supporting “confirmed disability improvement” reported in a pivotal clinical trial. Nearly one-quarter of the 5, 384 patients enrolled, particularly those new to treatment, experienced a decrease of at least one…
Switching to Ocrevus (ocrelizumab) within a relatively short period is a safe and effective option for people with relapsing-remitting multiple sclerosis (RRMS) who stop treatment with Tysabri (natalizumab), a small and retrospective analysis suggests. With a median washout period of six weeks between therapies, the 28 patients in this study…
MS News That Caught My Eye Last Week: Gilenya and COVID-19, Depression, Switching from Tysabri
Gilenya May Help Control Severe Respiratory Disease in COVID-19 This story caught my eye, but not because of the possibility that Gilenya may help someone recover from COVID-19. It caught my eye because this information may give false hope to some people. Some doctors think that at a…
The risk of a relapse is two to three times higher in relapsing-remitting multiple sclerosis (RRMS) patients who switch from Tysabri (natalizumab) to an oral or other injectable…
Biogen has released new data on several of its therapies for multiple sclerosis (MS), including Vumerity (diroximel fumarate), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab). The data — six presentations — originally were to be presented at the 2020 annual conference of the American…
Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…
The likelihood of discontinuing treatment with Tysabri (natalizumab) is higher among patients with progressive relapsing multiple sclerosis, and those who smoke and are depressed, a study reported. Progressive relapsing MS (PRMS) is now largely considered a subset of primary progressive MS, or PPMS marked by periods…
Multiple sclerosis (MS) patients switching from Tysabri (natalizumab) to other disease-modifying therapies may have an increased risk of disease activity, though the risk is lower if the switch is limited to three months, a study found. The results were published in an article, “Effect of…
MetP Pharma Awarded US Patent for Potential Remyelination Therapy Mention remyelination and the reaction from most of us with multiple sclerosis is probably, “How soon?” This announcement makes me hope that it’s now a little sooner. The process combines testosterone with a compound that changes the activity of something…