EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs I’m highlighting this report because, like several Europe-based doctors I know, I think that this decision is an overreaction. While there have been serious complications associated with Lemtrada (alemtuzumab), forcing a patient to…
Drug information
Pharmascience recently launched pms-Fingolimod, a generic version of Novartis’ Gilenya (fingolimod), to treat adults with relapsing-remitting multiple sclerosis (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya. Generic medicines are chemically identical to the original branded therapy, but carry a…
EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs
Seven months after starting a safety review of Lemtrada (alemtuzumab), the Pharmacovigilance Risk…
Teva Canada announced that Teva-Fingolimod 0.5 mg capsules, a bioequivalent generic version of Novartis’ Gilenya (fingolimod), are now available in Canada and approved by the country’s national health system called Health Canada. Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost. Canadian…
It’s time for another update on how I’ve been doing with my Lemtrada (alemtuzumab) treatments. The bottom line is that I’m doing well. Lemtrada is a disease-modifying therapy (DMT) delivered in two stages. The first stage entails a series of five daily infusions, while the second stage involves…
Interferon therapy (brand names Avonex, Betaseron, and others) is more effective than glatiramer acetate (sold as Copaxone, Glatopa and other generics) for reducing relapses…
Long-term treatment with Gilenya (fingolimod) in patients with relapsing forms of multiple sclerosis (MS) is safe and effective, results from a Phase 3 trial show. Trial findings were reported in the study, “Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results,” published in…
Newer disease-modifying treatments for multiple sclerosis (MS) are effective but also known to carry a greater risk of infections in a patient group already more likely to be troubled by infections — and this higher risk is particularly evident in treatment with rituximab, a DMT often used off-label in…
Early treatment with Tysabri (natalizumab) of patients with aggressive pediatric-onset multiple sclerosis is highly effective at achieving disease activity-free status and preventing cognitive decline, a new study shows. The study, “No evidence of disease activity including cognition (NEDA-3 plus) in naïve pediatric multiple sclerosis patients treated with natalizumab,”…
Metformin, a common diabetes treatment that works to mimic dietary fasting, was seen to promote remyelination in the stem cells of elderly rats, suggesting it may be useful in treating multiple sclerosis. “Metformin Restores CNS Remyelination Capacity by Rejuvenating Aged Stem Cells” was published in…
Prescriptions of two multiple sclerosis (MS) treatments — Merck KGaA‘s Mavenclad (cladribine) and Roche‘s Ocrevus (ocrelizumab) — have been rising in Europe over the past six months, bolstered by greater market access and compassionate use programs, according to a survey of 250 EU neurologists run…
The U.S. Supreme Court gave a green light to generic versions of Ampyra this week, declining to hear Acorda Therapeutics‘ appeal of a lower court ruling that allowed generics of its treatment for walking or gait problems in multiple sclerosis. That lower court ruling came from the U.S. District Court…
In this week’s column, I’ve changed the format a little to focus on one subject: rituximab. This is an approved cancer medication that some U.S. neurologists use as an off-label treatment for multiple sclerosis (MS). Rituximab is similar to Ocrevus (ocrelizumab). When the latter disease-modifying therapy (DMT) became available in…
People with relapsing-remitting multiple sclerosis (RRMS) who don’t use disease-modifying therapies (DMTs) are more likely to have been misdiagnosed previously, and to have poorer relationships with their healthcare providers, the results of a new survey suggest. The survey, titled “Multiple Sclerosis In America 2019,” was conducted by …
Editor’s note: This is the third story in a three-part report examining the question, “Is rituximab a reasonable alternative treatment for MS?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we take an in-depth look…
Editor’s note: This is the second story in a three-part report examining the question, “Is rituximab a reasonable alternative treatment for MS?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we take an in-depth look…
Editor’s note: This is the first story in a three-part report examining the question, “Is rituximab a reasonable alternative treatment for MS?”, which was a topic discussed at this year’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Here, we provide a synopsis of…
Acthar Gel (repository corticotropin injection) eased flare-up symptoms in patients with multiple sclerosis (MS) experiencing relapses, top-line data from an observational registry study shows. Acthar Gel, a medication developed and marketed by Mallinckrodt Pharmaceuticals, is a compound that enhances the production of steroids in the…
If necessary, women with relapsing multiple sclerosis can continue treatments based on interferon beta while pregnant and breastfeeding, according to an updated recommendation by an office of the European Medicines Agency (EMA). Interferon beta-based treatments are a mainstay of approved MS therapies. Three specific treatments were mentioned in press…
EMD Serono (Merck KGaA in Germany) is opening two pivotal and global Phase 3 clinical trials to evaluate the effectiveness and safety of oral evobrutinib in people with relapsing multiple sclerosis (MS). Evobrutinib, also known as M2951, works by blocking a protein called Bruton’s tyrosine kinase (BTK), which is…
The most recent data continue to support Mayzent‘s (siponimod) benefits and provide more insights on how this therapy can make a difference for those with relapsing forms of multiple sclerosis (MS) — in particular, data showing the therapy lowers the risk of becoming wheelchair-dependent. New results from…
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…
Two years after the approval of Ocrevus (ocrelizumab), the latest data continue to support the benefits of the so-called “game-changing” therapy in multiple sclerosis (MS), while new insights highlight its neuronal protective effects and safety. Multiple Sclerosis News Today had the opportunity to speak with Hideki Garren,…
Celgene‘s oral ozanimod, if approved, could be a first-line oral treatment option for people with relapsing multiple sclerosis (MS), and one with relatively minor side effects. Recent results from the Phase 3 trials RADIANCE (NCT02047734) and…
Actelion‘s ponesimod, an investigational oral treatment, is superior to Sanofi‘s Aubagio (teriflunomide) in lessening the frequency of relapses and easing fatigue symptoms in adults with active, relapsing multiple sclerosis (MS), results of the OPTIMUM trial show. These data will lay the ground for submissions…
#ECTRIMS2019 – Data Shows Ublituximab’s Long-term Safety in Relapsing MS, TG Therapeutics Announced
Ublituximab continues to be safe and well-tolerated by people with relapsing forms of multiple sclerosis (MS) after a median follow-up of 124.7 weeks — more than 2 years — according to data from an extension Phase 2 trial. The data were shown in a…
The U.S. Federal Trade Commission (FTC) sent warning letters to three companies that sell cannabis-based products containing cannabidiol (CBD), cautioning them that making unsubstantiated claims about the health benefits of CBD could lead to legal action. The agency “urges the companies to review all claims made for their…
Continuing Tysabri (natalizumab) treatment up to week 28 of pregnancy, and restarting soon after birth, reduces the risk of relapses in women with multiple sclerosis and appears to be safe for the mother and the baby, new research suggests. Doriana Landi, MD, PhD, from Italy’s University of…
Monthly under-the-skin injections of ofatumumab are superior to Aubagio (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
Mayzent (siponimod) reduces the risk of people with secondary progressive multiple sclerosis (SPMS) becoming dependent on a wheelchair, a new analysis of the EXPAND study shows. These findings further corroborate prior trial data demonstrating that Mayzent use delays disability progression and cognitive decline in SPMS patients. The results…