Truxima, a biosimilar of rituximab, is comparable to the originator therapy in terms of effectiveness and safety for treating multiple sclerosis (MS), a new study suggests. Rituximab — marketed as Rituxan in the United States — is an antibody-based therapy that works by killing B-cells, which are immune cells…
treatment
EHP-101, a cannabidiol-derived investigational therapy being developed by Emerald Health Pharmaceuticals (EHP) to treat multiple sclerosis (MS), is not a controlled substance in Canada, the company announced. The active ingredient in EHP-101 is a derivative of cannabidiol, abbreviated CBD. This is one of the most well-known active compounds in…
The Committee for Medicinal Products for Human Use (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS). Opinions released by CHMP, an arm of the European Medicines Agency (EMA), are generally accepted by the European Commission,…
ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…
The neurotechnology company Helius Medical Technologies has received authorization from Health Canada to market its portable neuromodulation stimulator (PoNS) device to treat gait deficit in patients with mild-to-moderate multiple sclerosis…
The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS),  active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the investigational new drug (IND) application to assess IMS001 in the treatment of multiple sclerosis (MS), ImStem Biotechnology announced. The company plans to start a Phase 1 study in the U.S. this…
A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosis has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…
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…
Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show. That means Gilenya provides an effective treatment option for…
An investigational therapy that uses nanocrystals of gold to help the brain repair itself represents a breakthrough in the multiple sclerosis (MS) field, says Clene Nanomedicine‘s chief medical officer Robert Glanzman. Glanzman, MD, recently presented promising results at the ACTRIMS Forum 2020 indicating that Clene’s lead…
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…
Sativex (nabiximols), a THC:CBD oral spray, consistently relieves the pain and severity of treatment-resistant spasticity in multiple sclerosis (MS) patients, according to a recent study. An analysis of the Sativex as Add-on therapy Vs. further optimized first-line ANTispastics (SAVANT) study revealed that Sativex, used in…
Ponesimod may soon be a new oral therapy for people with relapsing multiple sclerosis (MS) in Europe, and a filing for its approval in the U.S. is likely within weeks. Janssen Pharmaceuticals, its developer, submitted an application to the European Medicines Agency (EMA) in early March, a first ponesimod filing…
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…
Health Canada has approved Novartis‘s Mayzent (siponimod) for the treatment of adults with active secondary progressive multiple sclerosis (SPMS) to delay the progression of physical disability. Active disease is determined either by the presence of relapses or magnetic resonance imaging features characteristic of inflammatory activity. Multiple sclerosis (MS)…
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…
Treatment for two months with N-acetylcysteine, or NAC — a natural molecule that enhances the levels of antioxidants — significantly improved metabolic activity in certain brain regions among people with multiple sclerosis (MS), a small clinical study reports. This increase in metabolic activity was accompanied by improvements…
Modulating the bacteria that reside in the gut by treating multiple sclerosis (MS) patients with probiotics, fecal transplants, or gut-related microRNAs may help to ease inflammation and disease severity, researchers with Brigham and Women’s Hospital suggest. Howard Weiner, MD, a group leader at the hospital, presented his team’s findings on…
A signaling molecule of the immune system called interleukin 13 (IL-13) may modulate the function of key immune cells involved in multiple sclerosis (MS), and their migration through the barrier that protects the brain and spinal cord. IL-13 is an “attractive molecule” and a potential avenue for treating MS,…
Emerald Health Pharmaceuticals’ investigational cannabidiol-derived EHP-101 continues to show potential to ease inflammation and myelin loss (demyelination) — a hallmark of multiple sclerosis (MS) — according to data from healthy volunteers and a mouse model of MS. The data support the advance of EHP-101’s clinical development into…
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…
#ACTRIMS2020 – Ofatumumab Self-injection Pen Equivalent to Prefilled Syringe, APLIOS Trial Shows
Using a patient-friendly autoinjector pen to take monthly doses of ofatumumab — an investigational B-cell therapy for relapsing multiple sclerosis (MS) — is bioequivalent to delivering it via a prefilled syringe, and would allow self-administration of the treatment at home, a study shows. Equal effects…
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…
Immune system cells can either trigger or suppress inflammation by controlling mitochondrial respiration — the process that occurs in mitochondria, the cells’ powerhouses, and results in the production of usable energy by cells — according to a recent study. This discovery raises the possibility that…
Potential Therapy, Anavex 2-73, Shows Ability to Protect Neurons and Promote Myelin in Early Tests
Anavex Life Sciences‘ investigational therapy Anavex 2-73 (blarcamesine) showed an ability to protect, repair, and induce the formation of oligodendrocytes — the cells that produce the protective myelin layer around neurons — in early cell testing, researchers reported. These findings, which further establish the therapy’s potential as a treatment…
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…
Flowonix’s Prometra II Pump System Receives FDA Approval for Use with Intrathecal Baclofen This new pump could be a major step forward for people with multiple sclerosis who use a pump to deliver baclofen directly into their spinal column. It uses a pressure-driven system rather than a motor-driven one,…
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…
The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for the treatment of spasticity across numerous conditions, including multiple sclerosis. Intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by…
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