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Sunday
Receptor variation influences Gilenya (fingolimod) efficacy in mouse MS models
Image Source: MAX-PLANCK-GESELLSCHAFT
Multiple sclerosis (MS) is an autoimmune disorder that results in demyelination of neurons. The FDA-approved drug fingolimod (Gilenya, FTY-720) modulates signaling by the bioactive lipid sphingosine-1-phosphate (S1P), which is linked to MS pathogenesis. Fingolimod treatment reduces relapse rates and neurologic disability in many individuals with MS; however, the drug is less effective in some patients. In this issue of JCI Insight, May Han of Stanford University and colleagues tested the hypothesis that genetic variants of the cell surface receptor that responds to S1P, S1PR1, may influence the efficacy of fingolimod.
Read more »
Labels: Study
Wednesday
Multimodal evoked potentials follow up in MS patients under Gilenya (fingolimod) therapy: STUDY
Sunday
Effect of Gilenya (fingolimod) on diffuse brain tissue damage in relapsing-remitting MS patients
Impact of a switch to Gilenya (Fingolimod) on depressive symptoms in patients with relapsing MS: An analysis from the EPOC (Evaluate Patient OutComes) trial: STUDY
Rebound Syndrome in Patients With MS After Cessation of Gilenya (Fingolimod) Treatment: STUDY
Image Source: AMSEL
Importance The appropriate sequencing of agents with strong immune system effects has become increasingly important. Transitions require careful balance between safety and protection against relapse. The cases presented herein highlight that rebound events after ceasing fingolimod treatment may happen even with short washout periods (4 weeks) and may perpetuate despite steroid treatment or the immediate use of fast-acting immune therapies, such as rituximab.
Read more »
Labels: Study
Wednesday
Gilenya (Fingolimod) Shown to Benefit Neurons as Well as Immune System
The immune system-suppressing multiple sclerosis (MS) drug fingolimod also has potentially beneficial effects on the nervous system, according to a recent study, “The multiple sclerosis drug fingolimod (FTY720) stimulates neuronal gene expression, axonal growth and regeneration.“ The article appeared online March 12 in an early version of the journal Experimental Neurology.
Read more »
Labels: Study
Gilenya (Fingolimod) trial INFORMS primary progressive MS strategy
By Eleanor McDermid, Senior medwireNews Reporter
Fingolimod is unable to slow disability progression or brain volume loss in patients with primary progressive multiple sclerosis (MS), show the findings of the INFORMS study.
Read more »
Labels: Primary-Progressive PPMS
Disease-modifying treatments for MS – a review of approved medications: STUDY
New MS Drug Shows ‘Excellent Profile’ in Preclinical Tests Against Approved Therapy
Akaal Pharma's AKP-11 meets or surpasses MS drug Gilenya in animal model of disease
Akaal Pharma, a developer of small molecule drugs for the treatment of inflammation and autoimmune diseases including multiple sclerosis (MS), recently announced highly positive preclinical trial results on the safety and efficacy of its drug candidate AKP-11 when compared to Gilenya (fingolimod, FTY-720), an oral MS drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing forms of the disease.
Read more »
End-of-Year Task: Renewing Your DMT Prescription for 2016
By Kim Dolce—December 8, 2015
December is upon us, and besides being the holiday season, ‘tis also the season to renew our prescriptions for disease-modifying therapies and reapply for co-pay assistance.
Read more »
Labels: Aubagio, Avonex, Betaseron, Copaxone, Rebif
The management and outcomes of Gilenya (fingolimod) first dose cardiac monitoring in UK patients with relapsing-remitting MS: STUDY
Novartis’ MS Drug Gilenya Prevents Activation of Key Immune Cells in Study: STUDY
In a recent study entitled “Myeloid cells as target of fingolimod action in multiple sclerosis,” a team of scientists investigated the impact of fingolimod (Gilenya, Novartis), an approved drug for multiple sclerosis (MS), on the reactivity of myeloid cells, a key group that comprises several immune cells that are activated in MS patients and the underlying cause of the disease. The study was published in the journal Neurology.
Read more »
Labels: Study
Information Update - MS drug Gilenya (fingolimod): Safety information on the risk of skin cancer and a rare brain infection
Health Canada is informing Canadians that the drug label (product monograph) for the multiple sclerosis drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML).
Read more »
Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy)
Prediction of disability progression in Gilenya (fingolimod) treated patients: STUDY
Pegylated Interferon Beta-1a for Multiple Sclerosis: VIDEO
The MD Magazine Peer Exchange "Modifying the Course of Multiple Sclerosis in New Ways: The Latest Advances in Treatment" features a distinguished panel of physician experts discussing key topics in multiple sclerosis (MS) research and management, including the latest insights into MS pathophysiology, new medication options and their application in clinical practice, and more.
Read more »
Labels: Aubagio, Lemtrada, Plegridy, Tecfidera, Video
Tuesday
Efficacy of Gilenya (fingolimod) in patients with highly active relapsing–remitting multiple sclerosis: STUDY
Gilenya (Fingolimod) vs Interferon in Relapsing-Remitting Multiple Sclerosis
An international team of researchers recently reported on the results of the extension of a trial comparing fingolimod and interferon beta-1a in relapsing-remitting multiple sclerosis. Basically, patients fared better when they took fingolimod, but it’s worth examining the details.
Read more »
Cases of Brain Infection Reported in MS Patients Taking Gilenya
Multiple sclerosis patients prescribed Gilenya (fingolimod) are now being informed about a handful of documented cases where the therapy was found to have led to a rare brain infection, according to the US Food and Drug Administration. The FDA has released a public warning indicating that cases of progressive multifocal leukoencephalopathy (PML) have been reported in several patients taking the drug. Even though these PML cases are the first to be reported and linked to the drug in patients who have no history of receiving any type of immunosuppressive therapy, the FDA is now mandating Gilenya’s manufacturer, Novartis Pharmaceuticals, add the appropriate warning to the drug’s label.
Read more »
Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy)
Cost-utility of Gilenya (fingolimod) compared with Tecfidera (dimethyl fumarate) in highly active relapsing-remitting multiple sclerosis (RRMS) in England: STUDY
Saturday
NHS Wales Approves Biogen’s Plegridy for Relapsing Remitting MS
Relapsing remitting multiple sclerosis (RRMS) treatment Plegridy (peg interferon beta-1a) by Biogen Idec, has just received Welsh NHS approval, which should make it available to patients by late October 2015. The decision follows NHS Scotland’s approval earlier this year, however, the biweekly interferon beta shot has yet to be made available in England’s NICE healthcare system. Plegridy was approved across several countries in the European Union in July of 2014.
Read more »
Safety and Tolerability of Gilenya (Fingolimod) in Latin American Patients with Relapsing-Remitting MS: The Open-Label FIRST LATAM Study: STUDY
Long-Term Study of Gilenya Shows Positive Results in MS Treatment
The results of the study involving 1,600 patients continue to highlight Gilenya’s safety profile and ability to reduce multiple sclerosis relapse rates.
Read more »
Recent Update to Gilenya Prescribing Information
A recent warning and precaution has been added to the prescribing information for Gilenya® (fingolimod, Novartis AG), an oral disease-modifying therapy for relapsing forms of multiple sclerosis. The warning adds Cryptococcal fungal infections to the list of possible infections for which people taking Gilenya are at increased risk. Anyone receiving this or other medications that can compromise immune system function should promptly report any new or worsening symptoms – both MS-like symptoms and other symptoms – to their neurologist.
Read more »
Thursday
Long-term (up to 4.5 years) treatment with Gilenya (fingolimod) in multiple sclerosis: results from the extension of the randomised TRANSFORMS study: STUDY
Researchers Suggest Short Transition Period Between Tysabri (Natalizumab) and Gilenya (Fingolimod) Therapies to Control RRMS Disease Activity
An international team led by researchers at the University Hospital Basel in Switzerland revealed that a short period of 8 to 12 weeks is the optimal timing to be considered when patients with relapsing-remitting multiple sclerosis (RRMS) are switched from natalizumab to fingolimod therapy. The study was recently published in the journal Neurology and is entitled “Switching from natalizumab to fingolimod, A randomized, placebo-controlled study in RRMS.”
Read more »
Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Tysabri
Sunday
Comparison of Relapse Rates in Multiple Sclerosis Patients Switching from Glatiramer Acetate (Copaxone) to Fingolimod (Gilenya) versus Those Remaining on Glatiramer Acetate: STUDY
Wednesday
Gilenya (Fingolimod) prescribed for the treatment of multiple sclerosis in patients before the age of 18 years: STUDY
FREE MS RESEARCH UPDATE: a comprehensive overview of research findings on all of the FDA-approved disease-modifying therapies, as well as many experimental treatments
This year's expanded MS Research Update incorporates new information about the approved disease-modifying therapies (DMTs), as well as numerous experimental drugs currently under investigation for the long-term treatment of multiple sclerosis (MS). Highlights and recent research results are provided for each drug. Please note that symptom-management drugs are not included in this report.
DOWNLOAD YOUR FREE PDF OR ORDER A FREE COPY
Labels: Aubagio, Avonex, Betaseron, Copaxone, Lemtrada, Rebif, Rituxan-Rituximab, Tecfidera, Tysabri
Randomized trial of vaccination in Gilenya (fingolimod) treated patients with multiple sclerosis: STUDY
Sunday
Gilenya (Fingolimod) effect on brain volume loss independently contributes to its effect on disability: STUDY
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Oral Gilenya (Fingolimod) or Intramuscular Interferon for Relapsing Multiple Sclerosis: STUDY
Gilenya (Fingolimod) does not impair T-cell release from the thymus and beneficially affects Treg function in patients with multiple sclerosis: STUDY
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In Vivo PET Imaging Demonstrates Diminished Microglial Activation After Gilenya (Fingolimod) Treatment in an Animal Model of Multiple Sclerosis: STUDY
Gilenya (Fingolimod) effect on brain volume loss independently contributes to its effect on disability :STUDY
Second-Line Therapy with Gilenya (Fingolimod) for Relapsing-Remitting Multiple Sclerosis in Clinical Practice: The Effect of Previous Exposure to Tysabri (Natalizumab): STUDY
Saturday
This Could Be Game-Changing News in the Battle Against Multiple Sclerosis
For a disease that affects more than 400,000 people in the United States and approximately 2.5 million around the globe, multiple sclerosis is arguably not getting its fair share of attention from drug developers and researchers. According to the National Institutes of Health, which has an annual budget near $40 billion, only $115 million is expected to be spent on MS research in 2015.
Read more »
Labels: Aubagio, Avonex, Daclizumab, Stem Cell, Tecfidera
In Vivo PET Imaging Demonstrates Diminished Microglial Activation After Gilenya (Fingolimod) Treatment in an Animal Model of Multiple Sclerosis
Sunday
Study Links Gilenya Side Effects to Low White Blood Cell Count
The findings of a new study suggest that side effects of the multiple sclerosis drug Gilenya may reduce the amount of certain types of white blood cells, depressing the body’s immune system in a previously undetected way.
Read more »
Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy)
Oral Gilenya (fingolimod) reduces glutamate-mediated intracortical excitability in relapsing–remitting multiple sclerosis: STUDY
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Second-Line Therapy with Gilenya (Fingolimod) for Relapsing-Remitting Multiple Sclerosis in Clinical Practice: The Effect of Previous Exposure to Tysabri (Natalizumab): STUDY
Does interferon beta therapy affect survival of multiple sclerosis patients? STUDY
Impact of a switch to Gilenya (fingolimod) versus staying on Copaxone (glatiramer acetate) or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial: STUDY
Categorical change in T2 lesion volume and clinical outcomes in the Phase III FREEDOMS and its extension study, evaluating Gilenya (fingolimod) in patients with relapsing-remitting multiple sclerosis: STUDY
Wednesday
David Osmond raises awareness for Multiple Sclerosis
David Osmond kicked off the opening ceremony at the Walk MS: Houston event on Sunday, Nov. 10. For David, the fundraising event for the National Multiple Sclerosis Society was part of his personal mission to bring more awareness to MS diagnosis and treatment. Both he and his father, Alan, have been diagnosed with MS.
Read more »
Singer David Osmond Pens Power Ballad About Life with MS
Ever since his diagnosis in 2006, singer David Osmond has been raising awareness of multiple sclerosis (MS) with appearances on “American Idol,” the “Today” show, “Entertainment Tonight,” and at countless events across the country. Now, this son of Alan Osmond, the eldest member of the legendary performing family from the 1960s and ‘70s, has teamed up with Novartis Pharmaceuticals to launch a campaign of hope aimed at those living with MS.
Read more » Pharmac consults on new MS drugs
Hundreds of patients with multiple sclerosis are set to receive faster access to new drugs that work better than their current ones.
Read more »
Labels: Tysabri
An observational comparison of Tysabri vs. Gilenya using JCV serology to determine therapy
STUDY: Tysabri (Natalizumab) to Gilenya (fingolimod) washout in patients at risk of PML
Upon withdrawing natalizumab, resumption of disease activity was soon observed, beginning 3–4 months after the last dose of natalizumab
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Labels: 500 Best PML Stories & Studies, PML (Progressive Multifocal Leukoencephalopathy), Study, Tysabri
Review of current MS treatments for physicians
Friday's News for Neurologists: Here's 276 New Studies from 10/1 to Friday 11/1
Labels: 500 Best PML Stories & Studies, Ampyra, Copaxone, For Doctors, PML (Progressive Multifocal Leukoencephalopathy), sativex, Study, Tysabri
Gilenya Reduces Relapse Rates In Multiple Sclerosis Therapy: Novartis
(Posted By: Josi Creek)
Sunday
Press Release: Surveyed U.S. Neurologists Would be Willing to Accept a Novel Primary-Progressive MS
BURLINGTON, Mass., April 8, 2014 /PRNewswire/
-- Decision Resources Group (DRG) finds that, for the treatment of
primary-progressive multiple sclerosis (PP-MS), surveyed U.S.
neurologists would be willing to accept a certain level of risk for a
therapy with proven efficacy on disability progression, likely owing to
the absence of approved therapies for this indication. This finding is
reflected by the fact that among hypothetical therapies assessed in
DRG's conjoint analysis tool, neurologists were most receptive to an
agent with the greatest efficacy improvement over the market's sales
leading therapy, Teva's Copaxone, but which was also associated with the
greatest risk of serious or life threatening side effects.
Other
key findings from the DecisionBase report entitled Chronic-Progressive
Multiple Sclerosis: Amid Substantial Unmet Need, What Magnitude of
Efficacy and Safety Do Neurologists and Payers Expect of a
First-To-Market Therapy for Primary-Progressive Multiple Sclerosis?:
- Unmet need: A therapy's effect on disability progression is weighted by surveyed U.S. and European neurologists as the most important efficacy attribute driving prescribing decisions for the treatment of PP-MS. However, according to available clinical data and interviewed experts' opinions, none of the profiled current or emerging therapies are differentiated from Copaxone on this attribute rendering it an area of high unmet need.
- Nerventra: Nearly all surveyed U.S. neurologists would prescribe Teva's emerging product Nerventra, with it capturing 24 percent of currently treated PP-MS patient share. Although not yet studied in PP-MS, interest in Nerventra stems from the product's putative neuroprotective effect, benign safety profile to date and once-daily oral administration.
Comments from Decision Resources Group Analyst Emma McFadden, Ph.D.:
- "Data suggest that surveyed U.S. managed care organization pharmacy directors are highly receptive to novel PP-MS therapies offering even modest improvements over Copaxone on disability progression. However, they are sensitive to the risk profile of such agents when making formulary decisions, with few willing to reimburse a therapy with greater than one percent risk of serious adverse events. This reluctance is likely owing to the high costs which can be incurred by riskier therapies, such as by the need for patient monitoring and potential hospitalization."
- "If proven effective in their respective ongoing PP-MS clinical trials, Novartis's Gilenya and Roche/Genentech's ocrelizumab both have considerable market potential. Even prior to the availability of PP-MS clinical data, surveyed U.S. neurologists indicate that they would prescribe these therapies to 20 percent of their currently treated PP-MS patients."
About Decision Resources Group Decision
Resources Group offers best-in-class, high-value information and
insights on critical issues within the healthcare industry. Clients rely
on this analysis and data to make informed decisions. Find out more
atwww.DecisionResourcesGroup.com.
All company, brand, or product names contained in this document may be trademarks or
registered trademarks of their respective holders.
registered trademarks of their respective holders.
Source Story: The above story is based on materials provided by prnewswire Note: Materials may be edited due to content and
Labels: 100 MOST POPULAR, Copaxone
Wow! It's no wonder MS is seen as a Cash Cow: THESE MS DRUGS BROUGHT IN THE MOST MONEY LAST YEAR
Teva
soaring out in front on a single product and it is no surprise that the
Generics pack are waiting in the rear ready for the copaxone patents to
expire starting May 2014. However Biogen are backing the most winners
with a staggering $5.8 billion worth of business. #2 Avonex Biogen Idec $3.0 billion
#3 Gilenya Novartis $1.9 billion
#4 Tysabri Biogen Idec $1.7 billion
#5 Betaseron Bayer $1.1 billion
#6 Tecfidera Biogen Idec $0.9 billion
#7 Rebif EMD serono $0.6 billion
#8 Ampyra Biogen Idec $0.3 billion
#9 Aubagio Sanofi $0.2 billion
#10 Extavia Novartis $0.2 billion
Read more »
Labels: 20 Best Stories & Studies, Ampyra, Aubagio, Avonex, Betaseron, Copaxone, Extavia, Rebif, Tecfidera, Tysabri
NOVARTIS WILL PAY TO GET MSers TO USE GILENYA
Novartis will pay out-of-pocket costs for non-Medicare patients who use Gilenya! PLUS: Novartis will also help patients navigate testing and monitoring recommended by the FDA, paying as much as $600 per patient for that expense.
Read more »
Labels: Rebif
Possible answer to chemo pain found in multiple sclerosis drug
Overview and safety of Gilenya (fingolimod hydrochloride) use in patients with multiple sclerosis
Scary Thoughts in Mice Fade on Novartis Multiple Sclerosis Drug Gilenya
Traumatic memories that haunt people with post-traumatic stress
disorder might be eased by a pill from Novartis AG now used to treat
multiple sclerosis, a study of mice suggests.
Click here to read more
Click here to read more
Solid growth from Tecfidera (Dimethyl fumarate) in the US and OUS
Click here to read more
Labels: Tecfidera
VIDEO: Dr. Timothy Vollmer
 |
| Dr. Timothy Vollmer |
There appears to be several different factors. One is genetics; the disease is more prevalent in people from Northern Europe. The second one is low Vitamin D levels early in life, and possibly in in-utero, increase the risk of MS subsequently," University of Colorado Doctor Tim Vollmer said.
He says people in Colorado are normally diagnosed with low-levels of Vitamin D. Some experts believe Vitamin D levels may be low in the state because of Coloradan's use of sunscreen.
Vollmer says new MS research and treatments are progressing at a remarkable rate.
"The field Multiple Sclerosis is one of the most rapidly evolving fields of medicine right now. We have eight FDA therapies and three that are likely to be approved within the next year to 18 months. In the last year or so, we've developed a new blood test that would identify patients who are at risk of some of the serious side effects of the drugs. As a consequence, we can now identify people who are likely to do very well on a certain drug with a very low risk," Vollmer said.
Read more »
Labels: 100 MOST POPULAR, Dr. Timothy Vollmer, Tecfidera, Tysabri, Video