August 28, 2023 News by Lindsey Shapiro, PhD Tyruko, first Tysabri biosimilar, cleared in US to treat relapsing MS The U.S. Food and Drug Administration (FDA) has approved Tyruko (natalizumab-sztn) as the first biosimilar of Tysabri to treat adults with relapsing forms of multiple sclerosis (MS). The decision also marks the first approval of any biosimilar for MS in the country, according to the regulatory agency.
July 25, 2023 News by Marisa Wexler, MS PB006, biosimilar of Tysabri, favored for approval in European Union The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended that PB006, a biosimilar version of Tysabri (natalizumab), be approved to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). The recommendation comes about a year after the regulatory agency…
August 15, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: COVID-19 Vaccines, Robot Training, Bladder Treatment, Tysabri Anti-CD20 Therapies Help Mount T-cell Response to COVID-19 Vaccines Since the start of the COVID-19 pandemic, there have been concerns that anti-CD20 therapies, such as Ocrevus (ocrelizumab), may interfere with the ability of a person with MS to fight a COVID-19 infection. But this report says that even if…
August 8, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Stem Cell Transplant, Tysabri, Exercise, Zinc Stem Cell Transplant Found to Reduce MS Relapses, Ease Disability This is excellent news for those of us who would like to see stem cell transplant for MS become more available and affordable. These researchers analyzed 50 studies covering a total of 4,831 people with MS, ages 26 to…
August 5, 2022 News by Lindsey Shapiro, PhD No Neuron Damage Increase With 6-week Switch to Tysabri: Study Switching from a standard monthly course of Tysabri (natalizumab) to an extended-interval dosing administered every six weeks does not seem to increase neuronal damage in people with multiple sclerosis (MS), a study found. While individual blood levels of neurofilament light chain (NfL), a biomarker of nerve damage, did…
August 1, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Vitamin D, Brain Health, Digoxin, Natalizumab No Link Between MS Severity, Vitamin D-related Mutations: Study Several studies over the years have indicated that there could be a link between a person’s vitamin D level and the risk of multiple sclerosis (MS). This study is slightly different. Researchers looked at whether genetic variations related to vitamin…
July 27, 2022 News by Margarida Maia, PhD Natalizumab, Biosimilar of Tysabri for Relapsing MS, Under FDA Review The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting thatĀ Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms ofĀ multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, coveringĀ clinically isolated…
July 19, 2022 News by Marisa Wexler, MS Natalizumab, Tysabri Biosimilar, Up for Approval in Europe The European Medicines Agency (EMA) has agreed to review a request to approveĀ Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, anĀ approved MS treatment. “The acceptance…
July 13, 2022 News by Steve Bryson, PhD For MS Patients in Japan, Kesimpta May Be Best at Preventing Relapses Kesimpta (ofatumumab) may be more effective at reducing relapse rates than other disease-modifying therapies (DMTs) in Japanese adults with relapsing forms of multiple sclerosis (MS), according to a review of clinical trial data. Although the differences were not statistically significant, the study provided comparative evidence that may help…
May 18, 2022 News by Lindsey Shapiro, PhD Gilenya, Tysabri Show Superiority at Preventing Relapses in Children Gilenya (fingolimod) and Tysabri (natalizumab) were more effective at lowering relapse rates in children with multiple sclerosis (MS) than interferon-beta, according to a recent meta-analysis. Findings like these can be leveraged for better clinical trial design, the researchers wrote. If used to determine “historical” relapse rates that…
May 9, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: Cannabis, Keto Diet, Tysabri, MS Unknowns Cannabis āHighly Effectiveā Against MS Symptoms, Some Users Report I would’ve expected many users to report that cannabis has been highly effective at treating MS symptoms, not just some. But comments about this study on the MS News Today Facebook page indicate that people have mixed results. Even…
May 3, 2022 News by Marisa Wexler, MS Tysabri Every 6 Weeks Found as Effective as Standard 4-week Dosing Tysabri (natalizumab) given every six weeks was found to be similarly effective as the standard four-week dosing schedule at stopping nervous system damage in people with relapsing-remitting multiple sclerosis (RRMS). That’s according to the full results of the Phase 3b NOVA clinical trial, which compared Tysabri dosing schedules…
March 2, 2022 News by Marisa Wexler, MS #ACTRIMS2022 ā Algorithm Predicts Relapse Risk Using EHR Data Using a two-step machine learning strategy, researchers have developed an algorithm to predict the risk of multiple sclerosis (MS) relapse based on data gleaned from electronic health records. “The two-step machine learning model predicts a patient’s future one-year MS relapse risk with clinically actionable accuracy, comparable to other clinical…
February 8, 2022 News by Marisa Wexler, MS Patients Who Stop Tysabri for Pregnancy at Higher Risk for Relapse The majority of multiple sclerosis (MS) patients who stop taking Tysabri (natalizumab) before or when they become pregnant experience a disease relapse during pregnancy or shortly thereafter, according to a study out of Germany. In more than one out of every 10 cases, relapses were so severe that…
December 7, 2021 News by Marisa Wexler, MS Worsening of Disability Evident in Older Patients Who Stop DMTs While older multiple sclerosis (MS) patients whose conditions are stable commonly stop using disease-modifying therapies (DMTs), a study indicates this decision can shortly lead toĀ a marked disease worsening in a substantial portion of them. “Our results raise important questions about the accepted practice of discontinuing medications once MS…
October 15, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Lower Relapse Rates Seen With Tysabri Than Ocrevus Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ here to see the latest stories from the conference. People withĀ …
October 13, 2021 News by Marisa Wexler, MS #ECTRIMS2021 ā Rituximab as First RRMS Therapy Outperforms Others Editorās note: TheĀ Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13ā15. GoĀ here to see the latest stories from the…
April 30, 2021 News by Forest Ray PhD FDA Rejects Under-the-skin Tysabri for Relapsing MS The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of TysabriĀ (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…
April 23, 2021 Columns by Ed Tobias Let’s Treat Older MS Patients With More Respect As comic Rodney Dangerfield might have said, older people with MS “just don’t get no respect.” By older, I mean those of us who are 55 and up. By respect, I mean from researchers and some neurologists. So, as I approach my 73rd birthday, I have to tip my cap…
April 23, 2021 News by Marisa Wexler, MS #AANAM ā Tysabri Improves Quality of Life, Can Reduce Infection Risk Editorās note: TheĀ Multiple Sclerosis News TodayĀ team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17ā22. GoĀ hereĀ 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…
April 8, 2021 News by Marisa Wexler, MS Under-the-skin Injection of Tysabri Approved in Europe The European Commission (EC) has approved a new method to administer Tysabri (natalizumab) as a treatment for people with relapsing-remittingĀ 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,…
March 31, 2021 News by Patricia Inacio, PhD In Real World, Tysabri Lessens Disease Activity, Reduces Relapses in Pediatric-onset MS Off-label treatment with TysabriĀ (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…
March 26, 2021 Columns by Ed Tobias Ocrevus and PML: Should We Be Worried? The journal JAMA Neurology recently reported that a 78-year-old man with progressive multiple sclerosis died after being diagnosed with progressive multifocal leukoencephalopathy (PML), a brain disease. The man, diagnosed with MS about 30 years ago, had been treated for two years with Ocrevus (ocrelizumab), and had no previous…
February 22, 2021 News by Joana Carvalho, PhD Switch From Tysabri to Moderate-efficacy DMTs Linked to Worse Disability 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,…
January 25, 2021 Columns by Ed Tobias MS News That Caught My Eye Last Week: Nanocrystals, ‘Cog Fog,’ Mapping MS, Ocrevus Clene Awaits US Patent Covering Gold Nanocrystalsā Use in Treating MS This is a different approach to MS treatment. It uses very tiny crystals to produce a chemical reaction. It is hoped that this reaction will protect neurons and help to generate myelin. So far, there have only been…
January 21, 2021 News by Teresa Carvalho, MS New Study Will Assess Tysabri Effects on MS Cognitive Fatigue Researchers from the Kessler Foundation will launch a new study investigating the effects of Tysabri (natalizumab) on cognitive fatigue ā the type of fatigue that happens after strong mental concentration, such as in problem-solving ā in people with relapsing-remitting multiple sclerosis (RRMS). Cognitive fatigue, which is very…
December 30, 2020 Columns by Ed Tobias Will Reduced Treatment Time Keep Ocrevus Competitive? One of the key considerations when choosing a disease-modifying therapy (DMT) is how much it will disrupt your life. It’s one of several factors that need to be evaluated. Unlike shots and pills, infusion treatments can require a significant amount of time. That’s why the U.S. Federal Drug Administration’s December…
November 30, 2020 Columns by Ed Tobias MS News That Caught My Eye Last Week: More Tysabri Benefits, Long-term Ocrevus Data, Trial Diversity, MS and the Gut 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…
November 24, 2020 News by Steve Bryson, PhD Tysabri Affects Immune System Beyond Known MS Target, Study Finds 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.
November 9, 2020 News by Teresa Carvalho, MS Tysabri Superior to Gilenya at Easing Activity in RRMS, Study Reports Treatment with Tysabri (natalizumab) was more effective thanĀ Gilenya (fingolimod) in helping people with relapsingāremitting 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…