Drug updates

Long-term treatment with Ocrevus (ocrelizumab)  — as well as switching from Rebif (interferon beta-1a) to Ocrevus — leads to a significant and sustained reduction in disease activity in relapsing forms of multiple sclerosis (MS). These previously reported findings are further supported by the latest results drawn from pooled data…

Two multiple sclerosis medications that are both popular and expensive are on a new list that U.S. regulators hope will increase price competition. The medications are Ampyra (dalfampridine), made by Acorda, and Tecfidera (dimethyl fumarate), by Biogen. They’re included on a list of more than 50…

Continuous treatment with Ocrevus (ocrelizumab) or switching from Rebif (interferon beta-1a) to Ocrevus leads to a significant long-term reduction in relapsing multiple sclerosis activity, a two-year extension study shows. Ocrevus’s maker, Genentech, drew the results from an open-label extension of the Phase 3 OPERA trials. Researchers will present the findings at…

After a delay in treatment in late December thanks to a nasty head cold, and the after-effects of contracting the flu in February necessitating another delay, I finally received my second six-month dose of Ocrevus (ocrelizumab) in mid-March. Much like the first time, the infusion was uneventful. I had no…

Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…

Brabio (glatiramer acetate injection), the first generic alternative to Copaxone for relapsing multiple sclerosis (MS) patients, was recently launched in the U.K. at an equivalent higher dose, its maker, Mylan, announced. Similar to Copaxone  — developed by Teva — Brabio is now available at a 40 mg/ml dose. Both medications are…

European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU This is a biggie. It’s been nearly a year since the FDA approved the use of Ocrevus here in the U.S. Finally, it’s been given the green light in Europe. Canada, Australia, Switzerland, and various countries in…

The approved lymphoma therapy Rituxan (rituximab) has shown promise as a treatment for  multiple sclerosis. A new study indicates the Genentech treatment is effective and safe against neurological diseases like MS for up to seven years. The research, “Long-term safety of rituximab induced peripheral B-cell depletion in…

Multiple Sclerosis News Today brought you daily coverage of important discoveries, treatment developments, clinical trials, and other events dealing with multiple sclerosis throughout 2017. We look forward to providing more news to MS patients, family members, and caregivers during 2018. As a reminder of what mattered most to you in…

Britain’s National Health Service should cover the multiple sclerosis therapy Extavia, the National Institute for Health and Care Excellence (NICE) has recommended. The health service usually follows the institute’s recommendations. So NICE’s endorsement means there is a good chance the health service will begin covering the Extavia prescriptions that…

The giant ECTRIMS/ACTRIMS MS conference begins in Paris on Wednesday, Oct. 25, and this column focuses on several of the presentations on which Multiple Sclerosis News Today will be reporting during the week. #MSParis2017 – Mavenclad Reduces Relapses, Prevents New Lesions in Many RRMS Patients, Presentations Will…

New data on how Lemtrada and Aubagio perform in a real-world setting will be the focus of Sanofi Genzyme when the company showcases its research at the upcoming 7th Joint ECTRIMS-ACTRIMS Meeting in Paris this week. Researchers will also share information about the safety of a new investigational therapy, GLD52 (GZ402668), currently in a Phase 1 safety study. The TOPAZ study is one of the main data sources for the upcoming presentations. The study, which follows relapsing MS patients who participated in the CARE MS-I and CARE MS-II extension study , is a rich source of information on long-term outcomes. Researchers will share various aspects of disease outcomes and magnetic resonance imaging (MRI) data from patients followed up to seven years, with some presentations focusing solely on those who switched from treatment with interferon beta-1a. Among the Lemtrada highlights are findings demonstrating that Lemtrada does not appear to trigger birth defects. Another presentation compared Lemtrada to Genentech’s Ocrevus using a model that evaluated both the cost and effectiveness of the two drugs. The analysis suggests that Lemtrada more effectively treated relapsing MS and was also linked to lower costs over a 20-year period. Aubagio studies also focused on long-term patient data, including in people with progressive forms of relapsing MS. Data from the Phase 3 TEMSO , TOWER , and the TEMSO extension showed that Aubagio stabilized disability progression in these patients over nearly a decade. Other presentations homed in on Aubagio’s ability to slow brain tissue loss and improve cognitive outcomes. Finally, Sanofi Genzyme shared initial data on its investigational antibody GLD52. The treatment is an updated form of Lemtrada, which scientists believe gives rise to fewer and milder infusion-related reactions. Data from the Phase 1 study , so far indicated that this might indeed be the case, as no severe reactions occurred in the 44 progressive MS patients in the trial. For a complete list of Sanofi Genzyme's presentations at the meeting, visit this link.

Lemtrada (alemtuzumab) may be an effective option for relapsing-remitting multiple sclerosis (RRMS) patients withdrawing from prior treatment with Tysabri (natalizumab), an Italian study shows. The study, “High-Risk PML Patients Switching from Natalizumab to Alemtuzumab: an Observational Study,” appeared in the journal Neurology and Therapy. Tysabri, an antibody with…

New data on the recently approved multiple sclerosis (MS) drug Ocrevus (ocrelizumab) will be presented at the upcoming American Academy of Neurology (AAN) Annual Meeting 2017, which will take place April 22-28 in Boston. The meeting is the first scientific conference focusing on neurology since the U.S.

The U.S. Food and Drug Administration recently extended until the end of March its review of the Biologics License Application (BLA) for Ocrevus (ocrelizumab). The application was submitted by Roche, requesting FDA approval for Ocrevus as a treatment for patients with relapsing-remitting multiple sclerosis (RRMS) and — for a first…

Here are my Picks of the Week’s News, as published by Multiple Sclerosis News Today. Zinbryta Approved in Canada as Once-Monthly Treatment for Relapsing MS It can only be good for people with relapsing MS in Canada that they now may receive Zinbryta as a treatment.

Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…

  Here’s my Pick of the Week’s News, as published by Multiple Sclerosis News Today. Umbilical Cord Blood-derived Cell Therapy Promotes Remyelination in Mice Now this is different, using umbilical cord stem cells. A cell therapy product derived from human umbilical cord blood cells may be…

Oral therapy Tecfidera (dimethyl fumarate) seems to be emerging as a first-line treatment for relapsing multiple sclerosis – according to Biogen, the company that developed it. That’s good news, and something we need to know. The company agrees that for some time, the long-term effectiveness and safety of this oral…

Biogen, announced that TYSABRI, a drug developed to treat people with multiple sclerosis (MS) has received a positive opinion from the European Medicine Agency (EMA) recommending its approval to be used in people with elapsing-remitting multiple sclerosis (RRMS).

A new assessment by a European regulatory agency failed to find fingolimod of added benefit to comparator therapies for people with highly active relapsing-remitting multiple sclerosis (RRMS) who have failed to respond to treatment with at least one other disease-modifying drug. Fingolimod (Gilenya), developed as a therapy for multiple sclerosis, has undergone three early benefit assessments since its…

Delayed-release dimethyl fumarate (Tecfidera) was recently approved for patients with relapsing-remitting multiple sclerosis (RRMS), although the mechanisms by which the drug exerts its action were not fully understood. A new study from the University Hospital Münster, Germany, shows that dimethyl fumarate alters the balance between subpopulations of T-cells to promote…

Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation by the Data Monitoring Committee (DMC) that is supervising the clinical trials after cardiovascular events, none of which were fatal,…

Genzyme, a Sanofi company, recently announced novel positive 5-year experimental data from the extension study of Lemtrada® (alemtuzumab) in individuals with relapsing-remitting multiple sclerosis (RRMS). The findings were presented today, October 9, at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain. Lemtrada® (alemtuzumab), developed by Genzyme, is…

The world’s largest generic medicines manufacturer, Teva Pharmaceutical, is at the 31st European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress currently ongoing in Barcelona, from October 7-10, 2015. Teva will be presenting the latest findings on its relapsing multiple sclerosis (MS) therapy COPAXONE® (glatiramer acetate injection), and product candidate for…

Medical Need Europe, a privately held pharmaceutical company headquartered in Sweden and focused on registration, distribution, marketing and sale of orphan drugs and niche speciality pharmaceuticals for treatment of rare diseases, has appointed London, U.K. based Durbin PLC, a leading global supplier and distributor of pharmaceuticals, to manage…

A study recently published in the journal PLoS One compared the use of a specific treatment based on interferon beta-1a with other approved injectable therapies in patients with relapsing-remitting multiple sclerosis (RRMS). The study is entitled “A Network Meta-Analysis of Efficacy and Evaluation of…

The 67th American Academy of Neurology Annual Meeting took place last week in Washington, DC and included eight investigators from the Tisch MS Research Center of New York, whose research efforts focus on finding a cure for multiple sclerosis (MS). The researchers attended the meeting to share data and insights on…

MedDay, a biotechnology company that develops new drugs for nervous system disorders, announced an update on the progress of its development pipeline with its lead product MD1003 for the treatment of primary and secondary progressive multiple sclerosis (MS). The first study is expected to be complete in early 2015, while…

The Food and Drug Administration (FDA) recently accepted the results from Genzyme’s TOWER and TOPIC  clinical trials, which assessed the safety and efficacy of oral, once-daily Aubagio® (teriflunomide) for Multiple Sclerosis, and will add the positive data to the product’s U.S. label. Genzyme is a leader in the development…