CHMP Favors Mayzent as Oral Treatment Specifically for Active SPMS Patients in EU Mayzent (siponimod) is one of the newest disease-modifying treatments (DMT). I’m pleased that the Committee for Medicinal Products of Human Use (CHMP), which reviews treatments in the European Union, has recommended that the DMT be approved…
Disease modifying therapies (DMT)
The National Multiple Sclerosis Society has criticized Biogen for the $88,000 yearly list price it placed on Vumerity (diroximel fumarate), the newly approved oral disease-modifying treatment (DMT) for relapsing multiple sclerosis. That criticism extends to repeated price increases with Tecfidera (dimethyl fumarate), Biogen’s similar oral DMT for…
Long-term treatment with interferon beta (IFN-beta) corrects the defective immune balance characteristic of people with relapsing-remitting multiple sclerosis (RRMS), a study has found. The study also identified more than 200 genes with significantly different activity between complete and partial responders to IFN-beta treatment, which could be used to identify which…
Vumerity Approved in US as Treatment for RRMS and Active SPMS By my count, Vumerity is the 18th disease-modifying therapy (DMT) that the U.S. Food and Drug Administration (FDA) has approved for multiple sclerosis (MS). It’s one of very few approved for secondary progressive MS (SPMS). I find…
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…
People with multiple sclerosis (MS) tend to have low levels in their blood serum of certain antibodies that can protect against infection, regardless of whether they are using a disease-targeted therapy or not, a study reports. These levels were not so low as to risk infection on their own,…
A question raised by neurologist Gavin Giovannoni on the Barts-MS blog lit up my radar recently. Dr. G asked whether “elderly” people with MS should be treated differently than those who are younger. The question arises because a case of progressive multifocal leukoencephalopathy (PML), a serious brain disease,…
#ECTRIMS2019 – Are Injectables Inappropriate for Active Relapsing MS Treatment? Injectable disease-modifying therapies (DMTs) have been around for a long time. I took part in a Phase 3 clinical trial for Avonex (interferon beta-1a) in the mid-1990s. These treatments were the only game in town back then, and…
With more high-efficacy therapies becoming available, is it now inappropriate to prescribe older injectables — interferon beta and glatiramer acetate — to people with active relapsing multiple sclerosis (MS)? This question was at the core of what was called a “burning debate” at this year’s European Committee…
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,”…
Immunic Therapeutics announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapy for relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule. The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210…
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…
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…
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 …
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…
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…
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…
Age at disease onset is tightly linked to clinical outcomes in multiple sclerosis patients, a Swiss study in those on disease-modifying therapies (DMTs) reports. It found a risk of continuous relapses more likely in pediatric MS, and that of disease progression in those with adult-onset MS. Patients at age 40…
Relapses in people with multiple sclerosis (MS) are associated with greater medical and non-medical costs, according to real-world data from two German observational studies. These findings support early treatment with disease-modifying therapies (DMTs) that help to control disease relapses, its researchers said, as a way of possibly reducing such economic…
Using newer disease-modifying therapies (DMTs) as an initial treatment for children and adolescents with multiple sclerosis (MS) or clinically isolated syndrome (CIS) is associated with fewer relapses and brain lesions compared to the use of older and injectable DMTs, according to a real-world study in the U.S.
Oxcarbazepine, an anti-epileptic medicine, given in combination with a disease-modifying therapy (DMT) may help to stop disability progression in multiple sclerosis (MS) patients, results of Phase 2 trial suggest. Monica Marta, PhD, with Queen Mary University of London and Barts Health NHS Trust/The Royal London Hospital presented the data at the…
Women with multiple sclerosis (MS), and people who stay in a relapsing stage or use disease-modifying therapies (DMTs) for longer periods are less likely to transition to secondary progressive multiple sclerosis (SPMS) than others, according to a study based on the Italian MS registry. But patients whose…
New 10-year data from the Phase 3 ENDORSE trial confirms the long-term benefits of Biogen’s Tecfidera for patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of this disease. Real-world data from another study also showed Tecfidera to be superior to several other disease-modifying therapies for relapsing MS,…
#ECTRIMS2019 – MS Patients Should Be Informed about Pregnancy Risks and Family Planning, Experts Say
While pregnancy does not appear to affect the disease course of multiple sclerosis (MS), questions remain about the best time to stop or resume treatment before conception and after delivery, the safety of new medications, and the importance of family planning. Pregnancy was the “hot topic” discussion today…
Sandoz Enters Agreement with Polpharma Biologics to Develop and Commercialize Tysabri Biosimilar
Sandoz, a division of Novartis dedicated to the development of biosimilars, has entered an agreement with Polpharma Biologics, a biopharmaceutical company also dedicated to the manufacture of biosimilars, to develop and market a biosimilar to Biogen‘s Tysabri (natalizumab). Tysabri is a disease-modifying therapy (DMT) that was …
It probably comes as no surprise to you that the costs of some of the most popular MS medications have been soaring. A new study by researchers at the University of Pittsburgh reports that their list prices have more than quadrupled in a decade. And out-of-pocket costs rose even more.
The out-of-pocket costs for self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) patients on Medicare increased more than sevenfold from 2006 to 2016, according to a new study. This was reported by researchers at the University of Pittsburgh in a…
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