Pamela Arterbridge is one of 70 people at Ohio State University’s Multiple Sclerosis Center taking part in the open-label part of a clinical trial for ocrelizumab, now best known as Ocrevus. She is a patient of Dr. Michael Racke, who is a pioneer in the field of B-cell treatments for MS,…
RRMS
Texas firefighter Wayne Donovan is among the estimated 250,000 to 350,000 Americans with multiple sclerosis (MS). He enrolled in a clinical trial testing Ocrevus (ocrelizumab), which the U.S. Food and Drug Administration recently approved as the first therapy for both relapsing and primary progressive forms of MS. Donovan was diagnosed in 2011 at…
Ampyra (dalfampridine) shows long-term efficacy in improving walking ability in people with multiple sclerosis, according to a study evaluating the treatment’s use in progressive and relapsing MS patients over two years. The study, “Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis,” was published in the…
Ocrevus (ocrelizumab), now approved for both relapsing and primary progressive multiple sclerosis (MS), is expected to become available in the coming week. While patients and neurologists are waiting, Multiple Sclerosis News Today spoke to Genentech about the treatment’s approval, future research plans, and what patients can expect in terms…
The past few days have been remarkable in the multiple sclerosis (MS) community, with the U.S. Food and Drug Administration (FDA) approving Ocrevus to treat relapsing MS (RRMS) and primary progressive MS (PPMS) in the United States. Ocrevus — adminstered intravenously every six months — is the first drug…
Ocrevus Holds Promise, But Needs to Prove Itself in ‘Long Term,’ Says Dr. Robert Lisak with CMSC
Interest in Ocrevus (ocrelizumab), the first FDA-approved treatment for both relapsing and primary progressive multiple sclerosis, is running high among patients and the organization representing them — as, arguably, are expectations of its use. But how do physicians involved in MS care view the newcomer? Dr. Robert Lisak (Photo courtesy…
Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., has been selected to dispense Ocrevus (ocrelizumab), a limited-distribution drug, to people with relapsing and primary progressive multiple sclerosis. Ocrevus was approved by the U.S. Food and Drug Administration on March 28, becoming the first therapy approved for both RMS and…
Hope, But No Cheers Yet, Voiced by MS Groups in Europe and Canada Waiting on Own Ocrevus Decision
American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this first treatment for both primary progressive and relapsing multiple sclerosis (MS)?…
The historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which was also approved Tuesday as an unusually effective and safe treatment for relapsing MS, is viewed as a game-changer…
At long last, and for the first time in medical history, people with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab) as a disease-modifying therapy for both forms of MS, a chronic autoimmune disease.
An extension of a Phase 3 clinical trial has shown that early treatment with Rebif (interferon beta-1a) in patients with initial manifestations of multiple sclerosis (MS) can prolong the time to a clinically definite multiple sclerosis (CDMS) diagnosis over five years. The study, “Subcutaneous interferon β-1a in…
Alkermes has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera…
The United Kingdom’s National Institute for Health and Care Excellence (NICE) has cleared its initial doubts and now recommends Zinbryta (daclizumab) to treat relapsing multiple sclerosis (MS) in England and Wales. NICE had initially rejected Zinbryta after a first stage of the drug’s review process, due to some issues linked to…
A detailed analysis of relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections — serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…
Treatment with Apitope’s lead agent, ATX-MS-1467, decreased brain lesions in patients with relapsing multiple sclerosis (MS) in a now-completed Phase 2a clinical trial. ATX-MS-1467 is a potential disease-modifying agent with an immune-tolerating action. It consists of four short peptides derived from the myelin basic protein, and is designed to reduce…
Stem Cell Transplants of Greatest Benefit to RMS Patients at Earlier Disease Stages, Study Says
Stem cell transplants are most effective if done in young multiple sclerosis (MS) patients in early disease stages, who have not gone through several rounds of other treatments, according to a large study that followed transplant patients for more than five years. Study results also found that people with relapsing MS are much…
A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…
EMD Soreno has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Reduced brain atrophy rates are associated with lower risk of disability progression…
Here’s my Pick of the Week’s News, as published by Multiple Sclerosis News Today. Clinical Trial Supports Stem Cell Transplants to Treat RMS Patients with High Disease Activity It’s no secret to readers of this column and, indeed, to the wider MS community, that I am convinced…
A newly concluded clinical trial gives scientific evidence of the benefits that a stem cell transplant holds for multiple sclerosis (MS) patients who fail to respond to medications — with researchers calling the procedure a reasonable option for those with high disease activity. Five years after the treatment — high-dose immunosuppressive therapy followed by autologous hematopoietic cell transplant — further disease…
More relapsing multiple sclerosis (MS) patients treated with Zinbryta (daclizumab) said they felt its health benefits than did those given Avonex (interferon beta-1a) — demonstrating that patient-reported outcomes do mirror objective measures of improved health in a clinical trial of the two drugs. Patient-reported changes in both physical and psychological health contribute to a more comprehensive picture of…
The immune system B-cells responsible for producing antibodies are different in those who develop multiple sclerosis (MS) as children, than in those who develop it as adults, a study shows. The research, “B-cell populations discriminate between pediatric- and adult-onset multiple sclerosis,” was published in the journal Neurology: Neuroimmunology & NeuroInflammation. Because only 3…
When thinking about multiple sclerosis (MS), it’s important to remember there are four distinct types of the disease. Most of you well know this, so I’ll just mention them here: relapsing-remitting MS (RRMS); secondary progressive MS; primary progressive MS, and clinically isolated syndrome. (Anyone needing or wishing more information…
A modified Paleolithic diet reduced fatigue and increased the quality of life of patients with relapsing-remitting multiple sclerosis (RRMS), a study shows. The diet may also reduce inflammation by increasing vitamin K levels, the researchers said. The study, “Randomized control trial evaluation of a modified Paleolithic dietary…
An MS patient who reads my column sent a personal message last week. It began: “Sorry about the secrecy. I’m in the closet! Seriously, I haven’t told many people about my RRMS diagnosis, for many reasons. I really don’t want my kids knowing. … I want to spare them that…
GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b study — several months ahead of schedule. The company now expects to report topline results in mid- to late autumn rather than at year’s end. “Completing enrollment in CHANGE-MS several months sooner than previously anticipated…
Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far — working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…
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…
Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…
MS Patient’s Picks of the Week’s News: Zinbryta, Gadolinum, Calcium, Brain’s Defense, Antibiotic
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.
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