Cladribine

Bionxt Solutions has launched the final animal study needed to prepare for human testing of BNT23001, its sublingual version of cladribine, in people with multiple sclerosis (MS). The 15-day dosing optimization study will compare Bionxt’s thin-film formulation with the approved tablet version of cladribine, sold as Mavenclad, in…

Bionxt Solutions is getting ready to launch a pilot clinical trial to test BNT23001, its sublingual (under-the-tongue) version of cladribine to treat multiple sclerosis (MS). The treatment would be an alternative to Mavenclad, the approved tablet form of cladribine. Bionxt‘s thin-film formulation quickly dissolves under the tongue,…

Bionxt Solutions is preparing to launch a pilot clinical trial to compare BNT23001, its new sublingual, or under-the-tongue, formulation of cladribine, to the original medication Mavenclad to treat multiple sclerosis (MS). Mavenclad is a tablet formulation of cladribine that’s approved for adults with relapsing forms of MS. The…

A sublingual formulation of cladribine, which is the active ingredient of the approved oral treatment Mavenclad, in relapsing multiple sclerosis (MS), showed comparable pharmacological properties to its name-brand counterpart. That’s according to preclinical data announced by BioNxt Solutions, the formulation’s developer, in a company press release.

About three-quarters of multiple sclerosis (MS) patients given an under-the-skin formulation of cladribine had no disease activity or didn’t receive any additional therapies 4.5 years after starting treatment, a study shows. Cladribine is the active ingredient in the oral therapy Mavenclad and is typically given in two short treatment…

In December 2019, I was stopped in my tracks, or rather wheels, as I was about to have my third infusion of Ocrevus (ocrelizumab), the multiple sclerosis disease-modifying therapy (DMT) that I’d been taking every six months for the past year. My neurologist had decided just a few…

The safety and efficacy of the approved multiple sclerosis (MS) therapy Mavenclad (cladribine) in a real-world group of patients were similar to what had been demonstrated in clinical trials, a new study reports. Among 243 people with relapsing-remitting multiple sclerosis (RRMS), more than 60% showed no…

Patients with relapsing multiple sclerosis (MS) treated with subcutaneous cladribine saw limited disease progression over a follow-up period of up to 20 years, especially with increased cumulative dosing, according to a recent study. Subcutaneous (SC) cladribine is administered as an under-the-skin injection. It is a formulation different from…

Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…

Trial Will Test Mavenclad for Advanced Progressive MS I often think that researchers have forgotten about people whose MS has progressed to an advanced stage. But MS patients who have moved into a wheelchair deserve treatment with a disease-modifying therapy as much as those who are just beginning their…

Skin Reactions ‘Frequent’ With Mavenclad, Real-world Study Finds I regularly see people posting on social media about having a rash or itchy skin, or losing hair while taking Mavenclad. Researchers in this study say these side effects aren’t mentioned in the risk management plans for this disease-modifying therapy. Therefore,…

Skin reactions are common among relapsing-remitting multiple sclerosis (RRMS) patients being treated with oral Mavenclad (cladribine), affecting about one-third of the people evaluated in a real-world study in Germany. These findings suggest the need for careful clinical surveillance to rapidly diagnose and possibly treat skin problems stemming from Mavenclad’s use,…

Treatment with Mavenclad (clabridine) reduces the frequency of relapses in people with relapsing-remitting multiple sclerosis (RRMS), with benefits appearing to be evident two years after patients stopped taking the treatment, new data suggest. These findings were in the study, “Analysis of frequency and severity of relapses…

Are you being treated with a disease-modifying therapy (DMT) and wondering how it might affect the efficacy of an mRNA-based COVID-19 vaccine? If so, a recent study may provide some clarity. The study, published in Therapeutic Advances in Neurological Disorders, looked at 125 MS patients either being treated with…

Isn’t it just like me to start my column with a physics analogy that is already confusing? Please stick with me, as all will be revealed. My point is that if a black hole is big enough, you might slip through its event horizon without even noticing. There would…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, held April 17–22. Go here to read stories from the conference. After starting treatment with the multiple sclerosis (MS) therapy Mavenclad (cladribine), some types of immune cells are more affected…

Mavenclad (cladribine) reduces the number and volume of lesions in patients at risk of multiple sclerosis (MS) after a first clinical demyelinating event, a study based on Phase 3 trial data found. A demyelinating event occurs when myelin — the protective coating around nerve fibers — experiences damage; this…

An upcoming Phase 2 clinical trial, called ChariotMS, will test whether Mavenclad (cladribine) can slow a worsening of hand and arm function in people with progressive multiple sclerosis (MS) and very limited walking abilities. Patients reliant on wheelchairs or aids to walk even short distances generally have…

Eligible people with relapsing-remitting multiple sclerosis (RRMS) now have access to Mavenclad (cladribine) through seven provincial public drug plans in Canada, including the Régie de l’assurance maladie du Québec (RAMQ) and the Ontario Drug Benefit Exceptional Access Program. The oral treatment now is available through public drug programs…

EMD Serono will present new data from programs assessing the efficacy and safety of Mavenclad (cladribine) and Rebif (interferon beta-1a), as well as investigative evobrutinib in treating relapsing forms of multiple sclerosis (MS) at the MSVirtual2020 meeting. Findings are part of 54 abstracts being presented by EMD Serono,…

Paramagnetic Rim Lesions Showing Promise as Diagnostic Marker of MS About a year ago, researchers at the U.S. National Institutes of Health reported that the presence of chronic active lesions in the brain may provide a clue as to how quickly multiple sclerosis symptoms will progress. They called them…

Mavenclad (cladribine) prevents relapses and disease progression in more than half of patients with relapsing forms of multiple sclerosis (MS) for at least five years after the last dose, according to a real-life study from Italy. These findings, based on real-world data from Italian MS patients previously treated…

Note: A story mentioned in this column, “Prime Signs Agreement With EMD Serono to Improve Mavenclad’s Cost-benefit Value,” was updated on June 15, 2020, to clarify that the agreement allows for possible reimbursement for Prime’s health plan clients, not patients…

Note: This story was updated on June 15, 2020, to clarify that the agreement allows for possible reimbursement for Prime’s health plan clients, not patients directly.  Prime Therapeutics has signed an agreement with EMD Serono that may provide financial compensation for its health plan clients if their members…

The agency in charge of health and social services for Quebec, known as the Institut national d’excellence en santé et en services sociaux (INESSS), is recommending that Mavenclad (cladribine) be offered at discount to adults with relapsing-remitting multiple sclerosis (RRMS) enrolled in the province’s health system. INESSS’ opinions…

MetP Pharma Awarded US Patent for Potential Remyelination Therapy Mention remyelination and the reaction from most of us with multiple sclerosis is probably, “How soon?” This announcement makes me hope that it’s now a little sooner. The process combines testosterone with a compound that changes the activity of something…

The Committee for Medicinal Products for Human Use (CHMP) issued an opinion supporting Mayzent (siponimod) as an oral treatment specifically for adults with active secondary progressive multiple sclerosis (SPMS) in the European Union. Opinions released by CHMP, an arm of the European Medicines Agency (EMA), carry weight and are…

Mavenclad, Ocrevus Use Rising in EU as Injectables and Tysabri Decline, Spherix Reports I’m not surprised at reports that the use of Mavenclad (cladribine) and Ocrevus (ocrelizumab) is increasing in Europe, or that the use of injectable disease-modifying therapies appears to be declining there. Mavenclad and Ocrevus are approved…

In this column, I take a look at more exciting research from the ECTRIMS2019 conference this month. #ECTRIMS2019 – Ozanimod’s ‘Key Advantages’ May Lead to New First-line MS Therapy: Interview with Neurologist Jeffrey Cohen This year we’ve seen the approval of two new multiple sclerosis treatments in the United…

Real-world data continues to support the safety and effectiveness of Mavenclad (cladribine tablets) in treating multiple sclerosis (MS), and several studies underway will help scientists gain in-depth understanding of how Mavenclad works, its impact on the immune system, and the durability of its benefits, an executive with EMD Serono said in an…