Biogen

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…

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

A twice-daily dosing schedule and side effects like nausea and flushing are key reasons why more than 10% of multiple sclerosis (MS) patients followed for a year stopped using Tecfidera (dimethyl fumarate) as prescribed, a single-site study reports. Adherence to treatment is key to patients’ health, and doctors should not…

Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS). The company announced plans to…

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,”…

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…

Careful profiling of inflammatory markers in cerebrospinal fluid (CSF) of multiple sclerosis patients, coupled with standard exams and scans, helps in understanding disease evolution and treatment response, a case report suggests. It followed a relapsing-remitting multiple sclerosis (RRMS) patient whose inflammatory markers in the CSF remained high over time, and…

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…

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.

Biogen is presenting new data highlighting the potential clinical benefits of Tysabri (natalizumab), Plegridy (peginterferon beta-1a), and Avonex (interferon beta-1a) for the treatment of specific groups of individuals with multiple sclerosis (MS), including pregnant women and patients with relapsing forms of the disease. The new…

Use of plasma exchange (PLEX) is not effective for treating progressive multifocal leukoencephalopathy (PML), a dangerous brain infection that has been associated with using the multiple sclerosis (MS) medicine Tysabri (natalizumab), a real-world study contends. The findings highlight the importance of  closely monitoring Tysabri users to detect…

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,…

Oral ozanimod is more effective at reducing the frequency of relapses than Avonex (interferon beta-1a) in patients with relapsing forms of multiple sclerosis (MS), and does so with reasonable safety, results of Phase 3 trial show. These findings were described in the study, “Safety and efficacy of ozanimod…

Cathy Tolk, a multiple sclerosis (MS) patient and a motivational speaker, has opened a website that features her weekly articles, video blogs or  vlogs, inspirational messages, and mentions of two published books. Tolk, who lives in Connecticut, was diagnosed with MS in 1995 after years of bringing joy to…

Treating at-risk relapsing-remitting multiple sclerosis (RRMS) patients is most cost-effective with Mavenclad (cladribine) tablets when compared to Gilenya (fingolimod), Lemtrada (alemtuzumab) or Tysabri (natalizumab), according to a study in Dutch patients. The study, “Cost Effectiveness of Cladribine Tablets for the Treatment of Relapsing-Remitting Multiple Sclerosis in…

Treatment with rituximab — sold as Rituxan in the U.S. by Roche and Biogen, and as MabThera by Roche in Europe — reversed disease course in a “dramatic fashion,” leading to complete remission in a 12-year-old boy with aggressive relapse-remitting multiple sclerosis (RRMS), a case report states. The report, “…

Novartis‘ Gilenya (fingolimod), Sanofi Genzyme‘s Aubagio (teriflunomide), and Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate) are the top disease-modifying therapies to which patients with multiple sclerosis (MS) have most frequently switched in…

Fewer and less severe gastrointestinal (GI) side effects were evident in relapsing-remitting multiple sclerosis (RRMS) patients taking the investigational oral treatment Vumerity (diroximel fumarate) twice a day compared to those using Tecfidera (dimethyl fumarate), topline data from the EVOLVE-MS-2 trial show. Vumerity is a fumarate compound being developed…

A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oral bioequivalent in treating relapsing forms of multiple sclerosis (MS), Banner Life Sciences…

Scientists identified and “fingerprinted” a group of T-helper cells that are unusually numerous in the blood and central nervous system of people with relapsing-remitting multiple sclerosis (RRMS), and may be the reason behind the neuroinflammation seen in these patients. This T-cell population carries specific markers involved in the transmission…

Treating people with relapsing forms of multiple sclerosis (MS) with opicinumab and Avonex (interferon beta-1a) for 72 weeks did not lead to a dose-dependent reduction in disability,  results of a Phase 2 trial show. However, an ongoing study is evaluating opicinumab in a subgroup with better clinical responses.

Immune system activation induced by filgrastim may be beneficial for patients with progressive multifocal leukoencephalopathy associated with the use of Tysabri (natalizumab), without worsening multiple sclerosis (MS) progression, a study says. The study with that finding, “Treatment of natalizumab‐associated PML with filgrastim,” was published in…

A new artificial intelligence (AI)-based model is better than conventional methods for detecting brain changes in response to treatment with Tysabri (natalizumab) in patients with relapsing-remitting multiple sclerosis (RRMS), a study reports. The study, “High-dimensional detection of imaging response to treatment in multiple sclerosis,” was published in…

Vumerity (diroximel fumarate), taken as a 462 milligram (mg) tablet twice daily, significantly decreases disease activity in patients with relapsing-remitting multiple sclerosis (RRMS), and leads to low rates of gastrointestinal side effects, new interim data of Phase 3 trial EVOLVE-MS-1 show. The findings were presented at the 2019 Consortium…

#AANAM – Biogen Offers Update on Development Plans for MS Therapies The pharma company that brought you Tysabri (natalizumab) is investigating a new process for treating multiple sclerosis. The treatment looks for something called neurofilament light chain (NfL), a potential biomarker that’s released from damaged neurons.

At the 2019 annual meeting of the American Academy of Neurology (AAN), Multiple Sclerosis News Today sat down with Bernd Kieseier, MD, global head of multiple sclerosis at Biogen, to discuss the company’s portfolio, latest data, and therapeutic development plans in the field of multiple sclerosis (MS). Kieseier said…

New data suggests that treatment with Tysabri (natalizumab) in an extended interval dosing regimen is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS), compared with the standard interval dosing. The data was presented by Lana Zhovtis Ryerson, MD, on May 7 at the 2019 …

Treatment with Tysabri (natalizumab) lowers the levels of the biomarker serum neurofilament light chain (sNfL) in patients with secondary progressive multiple sclerosis (SPMS), according to data from a Phase 3 trial. Findings also revealed that higher levels of sNfL correlated with MS lesions and disease activity prior to starting the…

Infusible disease-modifying treatment — that is, therapies given intravenously — might have greater benefits for younger people with multiple sclerosis (MS) than oral ones, new research suggests. The research was presented at the ongoing American Academy of Neurology (AAN)’s annual meeting (May 4-10) by Brandi Vollmer,…