The balance between two immune signaling molecules — CXCL13 and BAFF — may help identify the hard-to-treat inflammation in the brain and spinal cord that’s thought to be a major driver of disability progression in multiple sclerosis (MS), a study found. The findings may help identify which patients are…
Drug information
The National Institute for Health and Care Excellence (NICE) in England is recommending natalizumab — sold as Tysabri and Tyruko — as an option for certain people with hard-to-control multiple sclerosis (MS). NICE is responsible for deciding which medicines will be covered by the National Health Service…
Tiziana Life Sciences‘ intranasal spray foralumab continues to be safe and well-tolerated, with no drug-related serious side effects reported after long-term use, according to an annual report filed with the U.S. Food and Drug Administration (FDA). The company is developing foralumab for neuroinflammatory diseases such as multiple…
Quantum Biopharma has completed dosing in two toxicology studies requested by the U.S. Food and Drug Administration (FDA) that aim to support the launch of clinical studies of Lucid-MS, an experimental treatment for multiple sclerosis (MS) that’s designed to slow myelin loss. The 180-day toxicity and toxicokinetic…
After months of delay, the U.S. Food and Drug Administration (FDA) has rejected Sanofi‘s application seeking approval of tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (MS). While Sanofi announced earlier this month that the decision was likely to be delayed again…
Specific disease-modifying therapies (DMTs) significantly slow the rate of brain volume loss in adults with multiple sclerosis (MS), a benefit that is directly linked to reduced long-term disability, according to a new review. A network meta-analysis of more than 26,000 patients confirms that therapies most effective at preserving…
Gadoquatrane, a contrast agent Bayer is developing for MRI scans, showed similar safety and pharmacokinetic (PK) profiles — meaning how a drug moves into, through, and out of the body — in both children and adults. That’s according to data from the Phase 3 QUANTI Pediatric study (NCT05915026),…
The U.S. Food and Drug Administration (FDA) has given tentative approval to Lupin’s Siponimod tablets, a bioequivalent version of Mayzent (siponimod), to treat people with relapsing forms of multiple sclerosis (MS). According to a company press release, the therapy is indicated for use in adults with clinically isolated syndrome,…
More than 3 million doses of Vueway (gadopiclenol), a lower-dose gadolinium contrast MRI agent used to diagnose and monitor conditions such as multiple sclerosis (MS), have been administered at more than 900 customer sites, maker Bracco Diagnostics said. Approved by the U.S. Food and Drug Administration for use in children…
Tyruko (natalizumab-sztn) is now commercially available in the U.S. as the first and only approved biosimilar to Tysabri for adults with relapsing forms of multiple sclerosis (MS). The therapy received approval from the U.S. Food and Drug Administration (FDA) in 2023 for all indications covered by the…
Zydus Lifesciences received final approval from the U.S. Food and Drug Administration (FDA) to market a generic version of Vumerity (diroximel fumarate) for adults with relapsing forms of multiple sclerosis (MS) and other conditions. The drug will be sold as 231 mg delayed-release capsules, produced at Zydus’s…
Sativex (nabiximols) — a cannabis-based oral spray used to ease spasticity in certain people with multiple sclerosis (MS) — has been acquired by CNX Therapeutics, which will now market the therapy in Europe and other international regions. The therapy, previously developed by Jazz Pharmaceuticals, is approved as…
Metis Biotech‘s experimental oral therapy MTS-004 was safe and eased symptoms of pseudobulbar affect (PBA), a neurological condition marked by bouts of sudden, involuntary, and inappropriate laughter or crying, in people with multiple sclerosis (MS) and other neurological disorders. That’s according to data from a Phase 3 clinical…
I’d spent about five years trying to figure out what was wrong with me and then treat it when I got the phone call. During that time, I’d had three surgeries to repair old injuries and had been treated for chronic Q fever. I’d also been diagnosed with multiple…
Zenas Biopharma has acquired global rights to develop the BTK inhibitor orelabrutinib to treat multiple sclerosis (MS) and other diseases. The deal with orelabrutinib’s developer, Innocare Pharma, includes rights to two other investigational therapies. Zenas will pay Innocare up to $100 million in cash and up to…
Increasing the dose of Ocrevus (ocrelizumab) by two- or threefold, depending on a person’s weight, did not provide additional benefit in slowing disability progression compared with the standard regimen in people with primary progressive multiple sclerosis (PPMS). That’s according to top-line data from the Phase 3b GAVOTTE…
Most people with relapsing forms of multiple sclerosis (MS) given Mavenclad (cladribine) did not experience confirmed disability progression for at least four years after starting on the approved therapy, according to new Phase 4 trial data. The results come from the CLARIFY-MS (NCT03369665) and MAGNIFY-MS (NCT03364036)…
Frexalimab, a therapy Sanofi is developing for multiple sclerosis (MS) patients, led to sustained reductions in disease activity in people with relapsing forms of MS over more than two years of treatment, while continuing to show a favorable safety profile. That’s according to new data from an…
Combining the diabetes medication metformin and the antihistamine clemastine significantly increased myelin repair in people with relapsing-remitting multiple sclerosis (RRMS), according to results from a Phase 2 clinical trial. However, the effects were small, and participants showed no improvements in disability or visual function after six months of treatment.
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…
TG Therapeutics has started enrolling participants in a Phase 3 trial to test a new version of Briumvi (ublituximab-xiiy) that can be injected at home. This change could offer greater convenience and flexibility for people with relapsing forms of multiple sclerosis (MS). The new formulation is given…
Immunic Therapeutics will receive a new U.S. patent covering its experimental therapy, vidofludimus calcium, and some related molecules in people with multiple sclerosis (MS). Titled “Treatment of multiple sclerosis comprising DHODH inhibitors,” the patent explicitly covers the use of the molecules in progressive types of MS, including primary…
The CD20 inhibitor Ocrevus (ocrelizumab) rapidly depletes immune B-cells in people with multiple sclerosis (MS), as expected, but ongoing treatment also leads to changes in immune T-cells, a new study reports. After about six months of treatment, patients experience T-cell changes such as an increase in regulatory…
Three biosimilar drugs — approved versions of brand-name therapies that have no clinically meaningful differences compared with their reference products — including one for multiple sclerosis (MS), will soon be available in the Middle East and North Africa (MENA) region under a new partnership between two pharmaceutical companies.
In the U.S., nearly 4 out of 5 neurologists prescribing therapies for multiple sclerosis (MS) have received payments from pharmaceutical companies that market MS treatments, according to a new analysis. The findings indicate that neurologists who receive payments from a company are significantly more likely to prescribe that…
Health Canada is warning that glatiramer acetate products, used in the country to treat relapsing-remitting multiple sclerosis (MS), may cause a severe allergic reaction called anaphylaxis, which can be life-threatening. The warning follows 11 reported cases of anaphylactic reactions linked to Copaxone — the original brand name of glatiramer…
A generic version of Ampyra (dalfampridine), used to improve walking in adults with multiple sclerosis (MS), is now available in the U.S. at a price its developer said is almost $1,000 a month lower than average. Civicascript will charge pharmacies $16 for each 60-tablet bottle, and recommends…
For children and adolescents with multiple sclerosis (MS), receiving treatment with Copaxone (glatiramer acetate) or its generic formulations may reduce relapses by nearly threefold compared with Avonex (interferon beta-1a), according to data from a clinical trial. However, nearly half of patients on Copaxone and one-third of those…
Researchers have identified a genetic biomarker that predicts whether people with relapsing forms of multiple sclerosis (MS) will respond to glatiramer acetate (sold as Copaxone, among others) therapy. A study based on an analysis of more than 3,000 MS patients showed that those who carry a form of…
People with multiple sclerosis (MS) may be significantly more likely to have relapses if their Medicare insurance covers fewer disease-modifying therapies, a study shows. The findings suggest that plans with narrower MS treatment coverage may be linked to worse health outcomes, possibly because the therapeutic response to complex diseases…