RRMS

The risk of a relapse is two to three times higher in relapsing-remitting multiple sclerosis (RRMS) patients who switch from Tysabri (natalizumab) to an oral or other injectable…

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…

Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…

The U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS). The label update draws on findings from a large population-based study, together with…

The European Medicines Agency (EMA) approved a shorter infusion time for Ocrevus (ocrelizumab), an approved treatment for people with relapsing or primary progressive multiple sclerosis (MS). The approval follows a positive recommendation from EMA’s Committee for Medicinal Products for Human Use (CHMP),…

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…

The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features. The EC decision follows a positive opinion issued in March by the European Committee for Medicinal Products for Human Use (CHMP).

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…

Glatopa, a generic form of Copaxone, is as effective as the brand-name medication in terms of disease outcomes and has similar healthcare-related costs in real-world use in patients with relapsing multiple sclerosis (MS), a new U.S. study suggests. Data also suggest a trend toward lower relapse rates with Glatopa…

People with progressive forms of multiple sclerosis (MS) have faster and disease-modifying therapy (DMT)-resistant retinal atrophy (thinning), compared to those with relapsing-remitting MS (RRMS), a study shows. Data also highlighted that the thickness of deeper layers of the retina could be used as potential biomarkers of neurodegeneration in…

I hate needles. Being told I’d need to do injections was the worst news ever, second only to my diagnosis of multiple sclerosis.  Sitting in the neurologist’s office with my husband, Paul, was terrifying. I was 22 and newly diagnosed with…

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 U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing…

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…

Starting treatment with Ocrevus early can lower almost by half the need for a walking aid in people with relapsing forms of multiple sclerosis (MS) over six years, new analyses of Phase 3 trial data that compared immediate initiation with a two-year delay show. A separate analysis also found…

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…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy using Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosis (RRMS). In the U.S., orphan drug designation is given to…

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…

The MIST Phase 2 clinical trial, supporting the potential of hematopoietic (blood cell-producing) stem cell transplant (HSCT) to significantly slow disability progression in highly active relapsing-remitting multiple sclerosis (RRMS) patients, has received a Distinguished Clinical Research Achievement Award from the Clinical Research (CR) Forum. Five years after the transplant, most…

“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…

Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people  with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report. Findings were reported in “Long-term safety and effectiveness of natalizumab treatment…

Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a), both by Biogen, may be used — if necessary — by women with relapsing multiple sclerosis who are pregnant or breastfeeding, the U.S. Food and Drug Administration (FDA) announced in updating prescribing information for these MS treatments. Due to the limited…

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,…

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…

I’m starting this week by linking to our Coronavirus COVID-19 Information section on the Multiple Sclerosis News Today Forums. My fellow moderator, John Connor, and I have been posting information there from our news writers and columnists about the evolving situation. Have You Tested Positive for Coronavirus…

Ethnicity does not seem to have an influence on the degree of cognitive impairment seen in patients at the early stages of multiple sclerosis (MS), a U.S.-based study suggests. The study, “Race, ethnicity, and cognition in persons newly diagnosed with multiple sclerosis,” was published in 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…

Older age, a greater number of health conditions, and prior hospital admissions are associated with more hospitalizations due to all causes among people with multiple sclerosis (MS). However, MS-related hospitalizations decrease as patients age, and are less frequent among women, according to a study analyzing more than two decades…

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…

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…