The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…
MS relapse
Am I Having an MS Relapse?
As I sit down to write this week’s column, it’s hard for me to concentrate. I’d planned to write about new MS mobile apps, but I can’t get my brain to focus on the task. I’ve been bragging about how I’ve been feeling sharper and able to concentrate better the…
Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial. The medication was also found to be more…
Note: This story was updated May 27, 2020, to note a change in the protocol of the EVOLUTION trials, which are now comparing evobrutinib with Aubagio, rather than Avonex, along with updated NCT numbers. The investigational oral medication evobrutinib leads to a sustained reduction in relapse rates…
Short and Sharp
This column will be short as I am quite ill. That’s nothing too unusual for those of us with MS. Oh, the joys of a relapse. A while back, it stopped me from walking. Now it’s stopped me from standing! Transferring anywhere is now a nightmare. I have to use…
Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the forum post, “Life Is Better with a Local MS Nurse?” published on August 24, 2019.
People with relapsing multiple sclerosis (MS) being treated with Gilenya (fingolimod) for eight or more years show smaller increases in disability over 10 years than those using this treatment for a shorter time, a long-term follow-up study reports. Longer use of Gilenya also resulted in lesser disability progression,…
The investigational anti-CD20 antibody ublituximab effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests. Findings further suggest that the…
The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…
Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…
“I can’t move my head,” I thought. It was 5 a.m. on April 1, and the realization of my full bladder prompted my wakening. But I soon realized I had a more significant issue that only became apparent when I tried to get up and couldn’t. What on…
Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimod to be approved as an oral treatment for adults with relapsing multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate…
Monthly under-the-skin injections of Novartis’ investigational candidate ofatumumab show promise as a convenient, effective, and safe therapeutic option for people with relapsing multiple sclerosis (MS). Data from the ASCLEPIOS and APLIOS clinical trials showed that ofatumumab — currently under regulatory review for possible approval in the U.S. and Europe…
Starting treatment with a disease-modifying therapy (DMT) reduces blood levels of neurofilament light chain (NfL) — a potential biomarker of disease progression and activity — to varying degrees depending on the therapy used, according to a large real-world study of patients with relapsing-remitting multiple sclerosis (RRMS). The findings support…
By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide…
Janssen has submitted an application to the European Medicines Agency (EMA) asking that ponesimod be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets the sphingosine-1-phosphate receptor…
Ozanimod — an investigational oral therapy up for approval to treat relapsing multiple sclerosis (MS) — lowers the number of white blood cells circulating in the blood, supporting its ability to ease inflammation in the brain and spinal cord. But this treatment also does not affect all…
Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…
Multiple sclerosis (MS) patients with depression are more likely to have worsening neurological function compared with those who do not have the mood disorder, results from a real-world study show. The findings were presented Feb. 27 by Jenny Feng, MD, in an oral presentation — titled “…
Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Novartis’ applications for ofatumumab — which has the…
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…
Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by the post, “Have you learned how to pace yourself?” from April 13, 2019. Have an…
When I wrote about April Hester two years ago, she and her husband, Bernie, had just finished hiking the 500 miles of South Carolina’s Palmetto Trail. That’s no small accomplishment for anyone, but it was a particularly special achievement…
Almost Half of MS Patients Change or Stop DMT Due to High Financial Burden, Survey Shows I frequently see reports of this on multiple sclerosis patient websites. People with MS say they’ve been forced to change or even stop their treatment because it costs too much. Some people have…
Recovering well after a first relapse and starting a disease-modifying therapy (DMT) immediately afterward considerably increases the likelihood of slowing progression in multiple sclerosis (MS), a study suggests. Its findings support relapse recovery as a critical factor for DMT initiation, and one that should be assessed routinely in MS…
A new clinical trial is comparing the best available therapies to an experimental stem cell therapy to treat severe forms of relapsing multiple sclerosis (MS). At the moment, more than a dozen therapies have been approved by the U.S. Food and Drug Administration for the treatment of relapsing forms…
The growing reliance on disease-modifying therapies (DMTs) to treat people with multiple sclerosis (MS) has led to fewer hospitalizations but not a drop in the number of physician visits, a population study of DMTs and their impact on healthcare use in Canada reports. The study, “Association between…
People with relapsing multiple sclerosis (MS) have a better prognosis and a slower progression to disability since the introduction of disease-modifying treatments (DMTs) some 20 years ago, according to a retrospective study. The study, “Outcomes in a Modern Cohort of Treated Multiple Sclerosis Patients Followed from Diagnosis Up…
Many multiple sclerosis (MS) patients consider autologous hematopoietic stem cell transplant (aHSCT) potentially effective in treating their disease, but most report needing more — and more reliable — information to make a reasoned decision regarding its benefits and risks, a survey found. Those who are dissatisfied with their current…
Women who breastfeed have a lower rate of multiple sclerosis (MS) relapses in the postpartum period compared to those who do not breastfeed or supplement it with regular formula, an analysis of published studies shows. The findings suggest that breastfeeding protects women from postpartum relapses, but due to the…
Recommended Posts
- MS causing fewer deaths, less disability than in the past: Study
- Living with MS migraines and navigating the ‘prior authorization’ trap
- Briumvi outperforms Aubagio in highly active relapsing MS: Study
- How I ‘keep moving’ in life with MS
- MS patients about twice as likely to have restless legs syndrome: Study