April 3, 2024 News by Margarida Maia, PhD Patients started early on Tysabri are less likely to relapse, study finds People who start treatment with Tysabri (natalizumab) soon after being diagnosed with multiple sclerosis (MS) are at a lower risk of relapse in the long term compared with patients who start on less effective disease-modifying therapies (DMT), a study has found. Patients on Tysabri, an antibody-based therapy,…
September 28, 2023 News by Andrea Lobo, PhD Tyruko, first Tysabri biosimilar, approved in Europe for RMMS The European Commission has approved Tyruko (natalizumab), the first biosimilar of Tysabri, for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The approval makes Tyruko available in the European Union for the same indication as its reference medicine. It also marks the first approval…
September 15, 2023 News by Andrea Lobo, PhD Benefits of long-term Tysabri seen in RRMS patients in Japan: Study Tysabri (natalizumab) significantly reduced the development of brain lesions on MRI scans in Japanese people with relapsing-remitting multiple sclerosis (RRMS), according to a new study. The therapy also eased or stabilized disability levels in most patients after five years of treatment, and significantly reduced the annual rate of…
September 1, 2023 Columns by Ed Tobias The 1st biosimilar OK’d as an MS DMT should save patients money The late August approval of Tyruko (natalizumab-sztn) by the U.S. Food and Drug Administration (FDA) is big news in the multiple sclerosis (MS) world. Tyruko is a biosimilar for Tysabri (natalizumab), and it’s the first biosimilar to gain FDA approval as an MS disease-modifying therapy…
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.
August 21, 2023 News by Steve Bryson, PhD GFAP protein levels in blood fail to predict disease progression in RRMS Levels of GFAP protein in the blood ā a marker of damage to support cells in the brain ā were associated with the enlargement of brain lesions and of fluid-filled brain cavities called ventricles in people with relapsing-remitting MS (RRMS) undergoing Tysabri (natalizumab) treatment, a study showed. While…
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…
July 12, 2023 News by Lindsey Shapiro, PhD Tysabri best of 6 DMTs to prevent relapses, worse disability in MS Tysabri (natalizumab) is better than five other disease-modifying therapies (DMTs) at reducing relapses and preventing disability worsening in relapsing-remitting multiple sclerosis (RRMS), according to the findings of a novel simulated clinical trial that directly compared the six treatments. The analysis used mathematical modeling to emulate a clinical trial…
June 29, 2023 News by Margarida Maia, PhD Ocrevus keeps MS activity stable after stopping Tysabri: Study Switching from Tysabri (natalizumab) to Ocrevus (ocrelizumab) does not appear to increase disease activity in people with relapsing forms of multiple sclerosis (MS) and stable disease, with most patients continuing to show no relapses or brain imaging findings one year after the transition, a clinical study shows.
June 9, 2023 News by Lindsey Shapiro, PhD Ocrevus best to prevent MS relapses after stopping Tysabri: Study Ocrevus (ocrelizumab) ā given by infusion ā may work better than certain oral treatments to prevent relapses and disability worsening in people with relapsing-remitting multiple sclerosis (RRMS) who transition from Tysabri (natalizumab), a new study found. Individuals who switched to Ocrevus also were more likely to stay…
May 4, 2023 News by Lindsey Shapiro, PhD Tysabri found to be safe and effective in real-world Danish study Tysabri (natalizumab) is generally safe and effectively lowers disease activity in people with multiple sclerosis (MS), according to a real-world study of patients over a 13-year period in Denmark. “Most patients treated with [Tysabri] are clinically stable with few adverse events,” researchers wrote. In more recent years, doctors…
February 3, 2023 News by Marisa Wexler, MS Biosimilar Comparable in Safety, Efficacy to Tysabri in Phase 3 Trial PB006, a biosimilar to Biogenās approved treatment Tysabri (natalizumab), showed similar safety and efficacy as the original medication in peopleĀ with relapsing-remitting MS (RRMS), according to data from a Phase 3 clinical trial. “The Antelope trial reported equivalence between [PB006 and Tysabri] treatment across efficacy, safety, and secondary…
November 2, 2022 News by Marta Figueiredo, PhD #ECTRIMS2022 ā Analyses Weigh Stem Cell Transplant Versus DMTs Autologous hematopoietic stem cell transplant (aHSCT) is superior to Gilenya (fingolimod) and Tysabri (natalizumab) at preventing relapses and reducing disability in people with highly active relapsing-remitting multiple sclerosis (RRMS). In turn, aHSCT appears to be as effective as Ocrevus (ocrelizumab) in RRMS patients and also was…
September 9, 2022 News by Marisa Wexler, MS Tysabri Improves Cognition Over Long-term in Early RRMS Patients Long-term treatment with Tysabri (natalizumab) significantly improves cognitive function and increases the chance of disability reduction in people with early relapsing-remitting multiple sclerosis (RRMS), according to data from the four-year observational STRIVE trial. Patients on Tysabri also reported improved quality of life and less impact of MS on…
September 8, 2022 News by Marisa Wexler, MS High-efficacy DMTs Boost Mid-term Prognosis for Relapsing MS: Study People with relapsing multiple sclerosis (MS) treated with Tysabri (natalizumab) or Gilenya (fingolimod) are less likely to have disease activity than those on low-efficacy MS medications, according to a small study conducted in Japan. Results also showed that patients receiving the high-efficacy therapies had less brain shrinkage,…
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 9, 2022 News by Lindsey Shapiro, PhD Tysabri Beats Other DMTs in Helping With Symptoms, Work Productivity Tysabri (natalizumab) outperforms other disease-modifying therapies (DMTs) in its ability to lessen a range of patient-reported symptoms in people with multiple sclerosis (MS), according to data from a large real-world study. These symptoms include balance difficulties, sensory problems, feelings of anxiety, bladder problems, vision problems, and…
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 11, 2022 News by Marta Figueiredo, PhD Low Levels of APP Molecule Found in Patients With MS-related Fatigue Multiple sclerosis (MS) patients with fatigue have significantly lower levels of amyloid precursor protein (APP) ā a molecule involved in nerve cell function ā in the cerebrospinal fluid (CSF) relative both to those without this common symptom and healthy people, a study shows. The CSF is the liquid…
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…
April 19, 2022 News by Lindsey Shapiro, PhD Long-term Gilenya Use Safe, Effective in Real-world Czech Study Treatment with Gilenya (fingolimod) for up to four years was found safe and lowered relapse rates among people with multiple sclerosis (MS) in the Czech Republic, according to a real-world study called GOLEMS. Older age, lower disability level, and fewer relapses prior to the treatment’s start were all…
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…