Genentech‘s experimental oral therapy fenebrutinib has become the first Bruton’s tyrosine kinase (BTK) inhibitor to show positive Phase 3 results in both relapsing forms of multiple sclerosis (MS) and primary progressive MS (PPMS), the company announced. In what Genentech called “unprecedented results,” two late-stage trials testing…
Drug updates
Note: This story was updated Sept. 23, 2025, to correct the generic name of Aubagio from tolebrutinib to teriflunomide. The U.S. Food and Drug Administration (FDA) has delayed by three months its decision on whether or not to approve Sanofi’s tolebrutinib as a treatment for multiple sclerosis (MS),…
A generic formulation of Zeposia (ozanimod), which won tentative approval for treating multiple sclerosis (MS) from the U.S. Food and Drug Administration (FDA), will be manufactured and supplied by Synthon, based in the Netherlands. Tentative approval means the generic version has met all FDA requirements for…
A new low-cost version of Tecfidera, a widely used oral therapy for relapsing forms of multiple sclerosis (MS), is now available in the U.S. for a fraction of the typical cost. Launched by Civicascript, this generic form of dimethyl fumarate is expected to significantly improve access to…
The U.S. Food and Drug Administration (FDA) has added a new boxed warning to the prescribing information for glatiramer acetate, an approved injection therapy for relapsing forms of multiple sclerosis (MS) that’s sold under the brand name Copaxone and is also available as generic products. A boxed warning…
TG Therapeutics is working to develop a subcutaneous, or under-the-skin, version of Briumvi (ublituximab-xiiy), its approved therapy for relapsing forms of multiple sclerosis (MS). The company said it plans to start a pivotal clinical program this year which could support an application seeking approval of the…
Immunic Therapeutics says it remains “on track” in testing its multiple sclerosis treatment candidate vidofludimus calcium in twin Phase 3 clinical trials with people who have relapsing disease — and in the Phase 2 CALLIPER study involving those with progressive forms of MS. Indeed, in a new company…
The rate of disability progression among people with relapsing-remitting multiple sclerosis (RRMS) has slowed over the years due to advances in disease-modifying therapies (DMTs), according to a long-term analysis. Patients diagnosed in recent decades have experienced fewer progression events associated with relapses, called relapse-associated worsening (RAW), and also…
An independent data monitoring committee has recommended that the twin ENSURE Phase 3 trials testing vidofludimus calcium in people with relapsing forms of multiple sclerosis (MS) continue as planned without adjustments. The opinion that the trials are worth continuing was based on a review of interim, unblinded trial…
The U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab), for treating adults with multiple sclerosis (MS). The approval covers all the same indications as the original medication, including relapsing forms of MS — namely…
A committee of the European Medicines Agency (EMA) is recommending the approval of a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) for people with multiple sclerosis (MS) in the European Union. The Committee for Medicinal Products for Human Use, known as CHMP, specifically recommended that this new formulation…
Viatris has launched a generic version of low-dose Copaxone (glatiramer acetate) in the Canadian market for the treatment of people with relapsing-remitting multiple sclerosis (RRMS) who retain the ability to walk. Called Glatiramer Acetate Injection 20 mg/mL, the product was approved in Canada as a generic of…
The prescribing label for Mavenclad (cladribine) in Great Britain has been extended to include the treatment of adults with active relapsing forms of multiple sclerosis (MS), as defined by clinical or imaging features. This decision made the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) the first to…
The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot — a long-acting formulation of glatiramer acetate — for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…
About two-thirds of people with relapsing forms of multiple sclerosis (MS) remained completely free from relapses over six years of treatment with Zeposia (ozanimod) in the DAYBREAK clinical trial. Most also saw no sustained disability progression during that period and the mean number of new or enlarging lesions…
Vanda Pharmaceuticals has acquired the U.S. and Canadian rights to Ponvory (ponesimod), an oral therapy approved for relapsing types of MS, in a new deal with Actelion Pharmaceuticals. Under the terms of the agreement, Vanda paid $100 million to Actelion (now part of Janssen), the therapy’s original developer. While…
Editor’s note: “MS News Notes” will return to its regular Monday morning schedule next week. Welcome to “MS News Notes,” a column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: A 10-minute injection of…
With a planned merger in the works, Frequency Therapeutics is no longer advancing its remyelination therapies for multiple sclerosis (MS), and instead is exploring “strategic alternatives for the program,” the company has announced. The regenerative medicine company, which had aimed to develop a new approach to treating MS…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Testing a new MRI contrast agent One concern that some people with MS have when getting an MRI…
Outcomes are better for people with relapsing-remitting multiple sclerosis (RRMS) initially treated with higher efficacy disease-modifying therapies (DMTs) than for those who begin with lower efficacy DMTs and escalate to more effective treatments as the disease progresses, according to a real-world analysis of patient registry data. Findings also…
Up to five years of treatment with Kesimpta (ofatumumab) continues to keep the number of relapses and brain lesions low in people with relapsing forms of multiple sclerosis (MS), with most patients showing no evidence of disease activity. These are new data from the ongoing ALITHIOS 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.
Ocrevus (ocrelizumab) appears to be more effective than rituximab at reducing relapse activity in people with relapsing-remitting multiple sclerosis (RRMS), but disability progression outcomes are comparable between the therapies, an observational study of patients reported. “Study findings suggest that the effectiveness of rituximab on MS relapses was…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Foralumab shows early positive results for SPMS I’ll say up front that this is a very small study.
Ocrevus (ocrelizumab) — given by infusion — 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…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Is CD40L a better way to control MS inflammation? CD40L is a protein that’s involved with activation of…
People with multiple sclerosis (MS) tend to accrue more medical costs after switching to infusible therapies Ocrevus (ocrelizumab), Tysabri (natalizumab), or Lemtrada (alemtuzumab), according to an analysis of data from commercially insured patients in the U.S. “The overall healthcare costs for MS patients increased a lot…
The benefits of Mavenclad (cladribine) were sustained for up to 15 years after its last treatment course in people with relapsing multiple sclerosis (MS), according to real-world data from the CLASSIC-MS study. More than half of those who received the oral therapy in the clinical trials that supported…
Welcome to “MS News Notes,” a Monday morning column where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s been happening: Good patient reviews for Sativex Sativex (nabiximols) is an oral cannabinoid spray designed to ease MS…
Note: This column was updated March 30, 2023, to remove the statement that Briumvi is more potent than Ocrevus or Kesimpta as there have been no trials comparing the three therapies’ potency. Welcome to “MS News Notes,” a Monday morning column in which I comment on multiple sclerosis (MS)…