Natalizumab

Natalizumab, Tysabri Biosimilar, Up for Approval in Europe

The European Medicines Agency (EMA) has agreed to review a request to approve 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, an approved MS treatment. “The acceptance…

#ACTRIMS2022 – 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…

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 to a marked disease worsening in a substantial portion of them. “Our results raise important questions about the accepted practice of discontinuing medications once MS…

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 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…

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…

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-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,…

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…

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 — 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…

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…

Tysabri Superior to Gilenya at Easing Activity in RRMS, Study Reports

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…