RRMS

The European Patent Office has released a Notice of Intention to Grant a new patent to support RHB-104 as a therapy for relapsing-remitting multiple sclerosis (RRMS). RHB-104 is being developed  by RedHill Biopharma. Patents covering the use of RHB-104 exist in over 25 countries, including the U.S., Australia, Canada, Japan, and in…

The Government of New Brunswick added  Lemtrada (alemtuzumab), by Sanofi Genzyme, to the New Brunswick Prescription Drug Program (NBPDP) through special authorization for eligible patients with relapsing-remitting multiple sclerosis (RRMS). New Brunswick joins other Canadian provinces, including Ontario, Saskatchewan, Quebec, and Manitoba, in making this treatment available to RRMS patients, ages 18 and older, who have had…

Health Canada has approved Teva Canada Innovation‘s three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing for patients with relapsing-remitting multiple sclerosis (RRMS). The approval was grounded primarily on data resulting from the Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical…

Multiple sclerosis seems to be less severe in people with higher levels of the minor adult hemoglobin variant A2 (HbA2) in their blood, according to a team of Turkish researchers. This could be due to this variant having a higher protective effect on the red blood cell membrane. The authors speculate that HbA2 could therefore be playing a role in reducing long-term neural injury in MS.

People with relapsing multiple sclerosis who use a device called RebiSmart (Merck Serono) to self-inject medications like Rebif (interferon [IFN] beta-1a) are more likely to take their therapies on a regular schedule and adhere to that schedule, resulting in fewer relapses than those not using the device, according to a retrospective study by  researchers…

Relapsing multiple sclerosis patients who begin taking Betaferon/Betaseron (interferon beta-1b) immediately after the first MS-related neurologic symptoms appear may realize slower disease progression than those who delay treatment, according to a study evaluating the therapy’s effects over a decade in patients enrolled in a Phase 3 clinical trial. The study, “The 11-year long-term follow-up…

Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., is now dispensing the limited-distribution drug Zinbryta (daclizumab) as a therapy for relapsing multiple sclerosis (MS). Zinbryta was recently approved by the U.S. Food and Drug Administration (FDA), and is indicated for the treatment of adult patients with relapsing MS.

Although Tysabri (natalizumab) is a highly effective in treating patients with relapsing-remitting multiple sclerosis (RRMS), some may develop progressive multifocal leukoencephalopathy (PML). According to a new study, this occurs because Tysabri impairs immune surveillance in the central nervous system and reactivates the latent John Cunningham polyomavirus (JCV). The study, “Natalizumab Affects…

RedHill Biopharma announced that the final patient has completed the last step of its Phase 2 clinical study (CEASE-MS) of RHB-104 as a potential treatment for people with relapsing-remitting multiple sclerosis (RRMS). RHB-104 is an antibiotic oral medication that blocks inflammation in addition to killing bacteria. RHB-104 was originally developed as a treatment for…

In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’s mechanism of action and B-cell biology…

A Phase 3 clinical trial exploring Ocrevus (ocrelizumab) in patients with relapsing-remitting multiple sclerosis (RRMS) is now recruiting participants. The trial, sponsored by Genentech (NCT02637856), is seeking patients who have previously taken a disease-modifying treatment that did not adequately control their disease activity. Participants must be between 18 and 55…

Now they tell me! People diagnosed with what is termed as benign MS can benefit from disease modifying drugs (DMDs), according to a new study. Fourteen years ago, when diagnosed as having MS, the neurologist told me that it was benign. He said it had taken 25 years to progress…

Sanofi Genzyme announced that the Government of Ontario has added Lemtrada (alemtuzumab) to the province’s Exceptional Access Program (EAP), opening coverage to the treatment for eligible patients with relapsing-remitting multiple sclerosis (RRMS). The program facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or those…

Patients with relapsing multiple sclerosis (MS) are being recruited for a clinical trial evaluating an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recent news release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100. MS is considered to be…

Merck KGaA, Darmstadt, Germany recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’s investigational product Cladribine Tablets as a therapy for relapsing multiple sclerosis (RMS) in Europe. Cladribine is a synthetic antineoplastic agent able to suppress the immune system, causing relatively few…

The Institute of Clinical and Economic Review (ICER), the nonprofit organization that released a preliminary draft last week intended to shape the Institute’s forthcoming report on the effectiveness and benefits of therapies for relapsing-remitting multiple sclerosis (RRMS), is made up of experts in healthcare policy from across the U.S. who, through the…

Disease-modifying therapies, a group of treatments for people with relapsing-remitting multiple sclerosis (RRMS), work to stabilize patients’ cognitive functions just as they do their physical symptoms. Research, conducted over the course of a year, also reported no differences between two types of DMTs, Gilenya (fingolimod) and Tysabri (natalizumab). The study, “…

You have just one week from today to have your say about the effectiveness of various disease modifying therapies (DMT) used to treat relapsing remitting multiple sclerosis (RRMS). Public comments are welcome in response to an early draft paper that is planned to be the basis for…

Biogen and AbbVie announced that the drug Zinbryta (daclizumab) has received marketing authorization by the European Commission, and is an approved treatment across most of Europe for adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a self-administered, once monthly subcutaneous injection. “Clinical data showed Zinbryta significantly reduced relapses, 24-week…

The Institute of Clinical and Economic Review (ICER) released the early draft of a paper intended to inform a future report evaluating the effectiveness and value of disease-modifying therapies for relapsing-remitting multiple sclerosis (RRMS). The paper, called a draft scoping document, is titled “Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis: Effectiveness and…

Since its approval by the U.S. Food and Drug Administration (FDA) in 2013, Tecfidera (dimethyl fumarate) has emerged as a first-line treatment for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS). While two separate clinical trials demonstrated Tecfidera’s ability to significantly reduce both the rate of relapse…

Fingolimod (Gilenya), a drug approved for patients with relapsing-remitting multiple sclerosis (RRMS) to prevent neuroinflammation, may also help these patients by directly enhancing nerve regeneration and increasing myelination in a way that is partly independent of its anti-inflammatory properties. The study reporting this finding, “Fingolimod promotes peripheral nerve regeneration…

Genmab announced plans to soon begin a Phase 3 clinical trial program assessing the subcutaneous formulation of ofatumumab as a potential treatment for relapsing multiple sclerosis (MS). The company, working in collaboration with its partner Novartis, will begin enrolling patients in September in trials that will evaluate the efficacy and safety of ofatumumab compared…

GeNeuro, a biopharmaceutical company that focuses on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced that the first patients with relapsing-remitting multiple sclerosis (RRMS) are under treatment with the company’s leading drug, GNbAC1, in a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…

Arrien Pharmaceuticals has initiated Phase 1 clinical trials of their first agent, ARN-6039, a molecule that targets a specific subset of immune cells called T helper 17 (Th17), for the potential treatment of patients with relapsing, remitting, and progressive multiple sclerosis (MS). A growing body of evidence has suggested a…