Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted New Drug Application (NDA) for cladribine tablets (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS). The regulatory agency agreed EMD…
treatment
MS News that Caught My Eye Last Week: Popular DMTs, Data Analysis Predicts MS, Remyelination Study
Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says Deciding on what therapy to use is a tough decision for people with MS and their doctors. That’s especially true for someone who is newly diagnosed. Do you go with…
New Therapy Candidates Could Provide Basis for Regenerative Medicines to Treat MS, Study Suggests
Therapy candidates that block enzymes responsible for making cholesterol can promote myelin regeneration, a discovery that could lead to new regenerative medicines capable of treating multiple sclerosis (MS) and other neurological diseases, according to a study. In fact, Convelo Therapeutics plans to do just that, announcing its intention to use…
African-Americans with relapsing–remitting multiple sclerosis (RRMS) show higher adherence and greater satisfaction when treated with oral Gilenya (fingolimod, by Novartis) than with injectable therapies, according to a new study. The research, “Treatment retention on fingolimod compared with injectable multiple sclerosis therapies in African-American patients: A…
Cladribine tablets added to interferon-beta treatment significantly reduced the probability of relapses over 96 weeks in people with active relapsing multiple sclerosis , a Phase 2 clinical trial found. But a troubling diminishment in key immune cells was also seen in treated patients. Relapsing-remitting MS is marked by periods of flares caused by inflammatory attacks, followed by periods of partial or complete recovery . A majority --about 65 percent -- go on to develop secondary progressive MS. Despite the growing number of treatment options — including disease-modifying therapies — for these MS patients, efforts continue into better ways to lower relapse frequency and slow disease progression. Researchers tested the safety and efficacy of cladribine tablets as an add-on therapy in patients continuing to experience active relapses while under interferon-beta treatment. Cladribine is an oral medication that works by selectively targeting and reducing the number of immune cells involved in the inflammatory attacks occurring in active MS. It was developed by EMD Serono (Merck KGaA outside the U.S. and Canada) and approved in the European Union using the brand name Mavenclad (it is not approved in the U.S. for MS). Interferon-beta works by balancing pro- and anti-inflammatory signals, reducing the number of immune cells and promoting the survival of nerve cells. Interferon-beta therapies are marketed under several brand names; in the study, researchers analyzed patients using Rebif (marketed by EMD Serono), Avonex (by Biogen), and Betaseron/Betaferon (by Bayer). The 96-week, randomized, double-blind, Phase 2b trial called ONWARD enrolled a total of 172 patients with active relapsing MS, who were randomly divided into two groups: those given cladribine tablets together with interferon-beta, and those that received a placebo and interferon-beta. Results showed those taking cladribine tablets together with interferon-beta had 63% lower likelihood of a relapse compared to those given an add-on placebo. Add-on cladribine treatment also reduced most measures of disease activity as assessed by magnetic resonance imaging (MRI) — namely, the number of new brain and spinal cord lesions. However, almost half of patients in this treatment group developed lymphopenia, a condition where the levels of lymphocytes (important immune white blood cells) in the blood are abnormally low. None in the control group developed the condition. Other reported side effects, including other serious adverse side effects, were identical in the two groups. Altogether, the findings indicate that a cladribine and interferon-beta combination can successfully lower the probability of relapses over the course of 96 weeks, but also increase a person's chances of lymphopenia.
Oral DMTs Still Common 1st Therapy for New MS Patients but Ocrevus Having Impact, Market Report Says
Oral disease-modifying therapies (DMTs) are the most common first choice of treatment for people newly diagnosed with multiple sclerosis (MS) in the United States, an analysis reports. Antibody-based DMTs like Ocrevus, however, are emerging competitors. Spherix Global Insights, a market research and analysis company, states that 1 in every…
Treatment with Tysabri (natalizumab) can help lessen sexual dysfunction in patients with multiple sclerosis (MS), a new study shows. The study, “Patient perceived changes in sexual dysfunction after initiation of natalizumab for multiple sclerosis,” was published in the Multiple Sclerosis Journal – Experimental, Translational and Clinical. MS is…
Blocking Protein Receptor Called M3R Seen to Promote Remyelination in Mice Model, Study Reports
Blocking a protein receptor called muscarinic type 3 (M3R) could be an effective way to promote remyelination in multiple sclerosis (MS) patients, according to a State University of New York at Buffalo (UB) study in mice. The research, “Muscarinic receptor M3R signaling prevents efficient remyelination by…
I’m now three months past my second round of Lemtrada treatments, so it’s time for an update. I began Lemtrada (alemtuzumab) in December 2016, hoping it will be the last disease-modifying therapy that I’ll ever need to use. I’ve had peaks and valleys since this treatment began, thus…
Cladridine may be effective in preventing disability progression and reducing damage to nerve cells in people with progressive forms of multiple sclerosis (MS), researchers suggest based on a case study of two such patients given the injectable treatment. MS is characterized by progressive degeneration of cells in the central nervous system, mostly…
Nicotine, the active agent in tobacco, and amyloid proteins, which underlie Alzheimer’s disease, bind to a receptor present in certain immune cells and work to lessen inflammation, a study reports. Activating this receptor — called the α7 nicotinic acetylcholine receptor — was seen to ease multiple sclerosis (MS) progression in…
The U.K.’s National Health Service (NHS) turned 70 last week. In England, yes, we are mourning our semi-final defeat by Croatia in the World Cup, but to most of us, the NHS is the U.K.’s crowning glory. There are innumerable problems and proposed solutions involving the institution, yet…
A common anti-parasitic agent showed a potential to prevent inflammation and to promote nerve cell recovery — remyelination — in a mouse model of multiple sclerosis (MS). By promoting the activity of a receptor called P2X4R that is present in microglial cells — immune cells that reside in the brain…
Brain volume loss takes place at a faster rate in the first five years of multiple sclerosis than later in disease course, researchers report in a study that calls for scientists to “reconsider” — for this and related reasons — proposals to use volume loss as a measure of treatment efficacy…
RRMS Patients Show High Levels of Satisfaction and Adherence to Gilenya Over 2 Years in Danish Study
People with relapsing-remitting multiple sclerosis in Denmark show high rates of adherence to treatment with Gilenya (fingolimod), and give the therapy high marks in terms of satisfaction and quality of life, a long-term study of its use by RRMS patients reports. The study, “High treatment adherence, satisfaction, motivation,…
NICE Agrees to Add Ocrevus to NHS for RRMS Patients in England and Wales, But Scotland Will Not
Relapsing-remitting multiple sclerosis (RRMS) patients with active disease may now be treated with Ocrevus (ocrelizumab, developed by Genentech) within the National Health Service (NHS) — the subsidized public health system that covers England and Wales. But those in Scotland will not. The National Institute for Health and…
Medical Cannabis Favored to Treat MS Spasticity and Other Ills by Doctors in Australia, Survey Finds
Most general practitioners in Australia favor prescribing medical cannabis to treat spasticity in multiple sclerosis (MS) or pain in select other diseases, but are not allowed to under current laws and say they know little about its use, according to results of a national survey. A study based on its…
An investigational cannabidiol-derived compound called EHP-101 may help to boost remyelination, prevent nerve cell damage and lower the reactivity of microglia cells — immune cells of the brain and spinal cord — a study in mouse models of multiple sclerosis (MS) reports. EHP-101, being developed by Emerald Health…
The National Institute for Health and Care Excellence, known as NICE, has decided against recommending that Ocrevus be part of public-funded treatments for adults with primary progressive multiple sclerosis (PPMS). The National Health Service (NHS) is the subsidized, publicly funded healthcare system for England, with similar structures…
Researchers confirmed that Sativex spray is beneficial in alleviating pain in patients with multiple sclerosis (MS), and also improved their pain sensitivity to cold temperatures. The study reporting the findings, “Pain Modulation after Oromucosal Cannabinoid Spray (SATIVEX) in Patients with Multiple Sclerosis: A Study with Quantitative…
A radioactive probe that might enable imaging tools to effectively monitor what a gene therapy is doing in the brain — important in treating diseases like multiple sclerosis with such a therapy — has been developed at Stanford University. The probe is a kind of radiotracer used successfully in this study…
Genentech‘s Ocrevus (ocrelizumab), approved in March 2017, has fueled a sea change in the treatment of multiple sclerosis (MS) patients in the U.S., leading to an increased interest in disease-modifying therapies (DMTs) for progressive forms of MS. Now, other potential treatment choices for progressive MS forms will likely…
New retrospective analysis of the Phase 3 CLARITY study (NCT00213135) shows that treatment with Mavenclad (cladribine tablets) improved annualized relapse rate and magnetic resonance imaging (MRI) outcomes in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of their age. Moreover, the effectiveness of Mavenclad was comparable to five standard therapies…
New treatment guidelines for multiple sclerosis (MS) patients in Europe were set in place through an initiative undertaken by the European Academy of Neurology (EAN) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Launched in parallel to the 4th Congress of the European Academy…
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…
Gilenya (fingolimod) and Tecfidera (dimethyl fumarate) are equally effective as first-line treatments in people with relapsing-remitting multiple sclerosis (RRMS), but Gilenya may be of slightly more benefit to those who switch from a previous injectable therapy, according to a real-world study of patients in Italy. The study, “…
Young adults with multiple sclerosis (MS) have higher relapse rates and respond better to Gilenya treatment compared to the overall MS population, data from a post hoc analysis of three separate trials show. The study, “Relapse Rate and MRI Activity in Young Adult Patients With Multiple…
A new way of interpreting inflammatory signals using the vagus nerve — which carries such signals from throughout the body to the brain — has been found, a study reports. This finding raises the possibility of having a kind of “early warning system” for inflammation, a damaging process in such…
Alkermes announced that it has received a $50 million payment from Biogen after a review of preliminary data related to the gastrointestinal tolerability of BIIB098 (diroximel fumarate), now in pivotal clinical studies as a possible treatment for relapsing forms of multiple sclerosis (MS). BIIB098, formerly known as ALKS 8700…
I’ve just dived into the misty world of the allergy medication clemastine. My, there’s a lot already written about it on this site. I was prompted by an article I’d saved on Facebook last year. In an idle moment — which have been pretty scarce lately…
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