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Labels: Aubagio, Avonex, Betaseron, Gilenya, Lemtrada, Rebif, Rituxan-Rituximab, TECFIDERA, Tysabri

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Labels: Lemtrada

NOMINEE FOR MS NEWS CHANNEL BEST ARTICLE OF 2013 AWARD

Lily K. Jung Henson, MD

The European approval of alemtuzumab (Lemtrada, Genzyme/Sanofi) means that there will soon be another new and exciting tool in the multiple sclerosis (MS) armamentarium. But how will this seemingly very effective agent fit in to current treatment?
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Labels: Lemtrada, MS News Channel Best of 2013 awards, Tysabri

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Labels: Aubagio, Avonex, Betaseron, Extavia, Gilenya, Lemtrada, Rebif, Rituxan-Rituximab, TECFIDERA, Tysabri

The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.

Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva Pharmaceutical Industries Ltd. (TEVA:US)’s Copaxone, Biogen Idec Inc. (BIIB:US)’s Tecfidera, Avonex and Tysabri, Novartis AG’s (NOVN) Gilenya and Merck KGaA’s Rebif.
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Labels: Avonex, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

BioTrends Research Group, a research and advisory firms for specialized biopharmaceutical issues, finds that physician-reported patient shares for Novartis's Gilenya and Biogen Idec's Tysabri are 8 percent and 10 percent among relapsing-remitting multiple sclerosis (RR-MS) patients treated with a disease-modifying therapy (DMT) across the EU5 (France, Germany, Italy, Spain and the United Kingdom); significantly higher than those reported by EU5 neurologists surveyed in 2012.
According to a release, surveyed neurologists also report that recent changes in treatment management include a shift toward earlier and more-aggressive treatment and increased use of the anti- JCV antibody assay, changes that are consistent with the increased patient shares reported for Gilenya and Tysabri. Survey data indicate that these agents occupy distinct niches, with Gilenya a preferred second-line therapy in JCV-positive patients and Tysabri a preferred second-line therapy in JCV-negative patients.

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada--and given the limited time these agents had been available at the time the survey was fielded--these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

"The European MS market is entering a dynamic period with two recent DMT launches and as many as six new DMTs launching in the next five years," said Decision Resources Group Senior Business Insights Analyst Georgiana L. Kuhlmann, S.M. "Our data find that gains for new brands will likely come at the expense of the interferon-beta therapies and Copaxone."

BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
Decision Resources Group is a cohesive portfolio of companies that offers information and insights on sectors of the healthcare industry.
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Labels: Aubagio, Avonex, Betaseron, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada—and given the limited time these agents had been available at the time the survey was fielded—these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

Labels: Aubagio, Avonex, Gilenya, Lemtrada, Rebif, TECFIDERA, Tysabri

An FDA advisory panel recently recommended the approval of Sanofi's multiple sclerosis drug, Lemtrada. However, that approval came among some mixed and contradictory opinions about the drug and the efficacy of Sanofi's trials.

On Nov. 13, the FDA panel voted 12-6 that Sanofi had provided enough evidence of Lemtrada's efficacy in patients with relapsed MS, but at the same time voted 11-6 that the company's trials had not been conducted thoroughly enough to properly assess the drug. After those seemingly contradictory opinions, the panel voted 14-0 that the drug should still be approved in December, despite its potential to cause cancer and other problems.

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Labels: Aubagio, Avonex, Gilenya, Lemtrada, TECFIDERA, Tysabri

"In our opinion, this will have a greater impact on Perrigo than Teva Pharmaceutical Industries Ltd.," says Clal Finance analyst Jonathan Kreizman. "The characteristics of Lemtrada are similar to those of Tysabri, because both drugs target more severe cases than Copaxone. Lemtrada and Tysabri are more effective than Copaxone, but have lower safety profiles."
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Labels: Lemtrada, Tysabri

Recognizing the need for better treatment options, big pharma has a slate of new oral MS drugs hitting the market.
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Labels: Aubagio, Avonex, Gilenya, Lemtrada, TECFIDERA, Tysabri

Director, Neurology Clinical Research Professor, Department of Neurology UNIVERSITY OF COLORADO Co-Director, Rocky Mountain MS Center at Anschutz Medical Director, ROCKY MOUNTAIN MS CENTER

ECTRIMS Congress 2013:  AMSTERDAM -- A low-dose regimen of the leukemia drug alemtuzumab (Lemtrada) slashed annualized relapse rates in patients with newly diagnosed multiple sclerosis in a head-to-head trial against interferon-beta-1a (Rebif), a researcher reported here.

Patients taking alemtuzumab -- first sold under the brand name Campath for treating B-cell chronic lymphocytic leukemia -- had a mean annualized relapse rate of 0.18 during a two-year, phase III trial, compared with 0.39 for patients receiving the standard regimen of interferon. But another neurologist not involved with the study suggested that the drug's safety profile remains a major concern.

Timothy Vollmer, MD, of the University of Colorado in Denver, said the extreme duration of alemtuzumab's effects was itself a potential problem.

"[It] induces long-term if not permanent changes in immunoregulation; it also induces significant generalized immune suppression and disturbance of immunoregulatory circuits," he observed.

As a result, said Vollmer, "once you treat a patient, you can't take it back. Those patients are then at risk for infections and for development of autoimmune disease."

He added that he considered these risks more worrisome than the potential for progressive multifocal leukoencephalopathy with natalizumab (Tysabri).

Coles reported findings from the 581-patient trial, dubbed CARE-MS I, during a late-breaking news session at the joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis.

Patients in the study had disease duration of no more than five years and EDSS disability scores of 3 or less, but had active disease on the basis of  relapses during the previous two years. Patients who had received disease-modifying therapies previously were excluded.

The difference in relapse rates meant the cancer drug met one of two primary endpoints in the study, which was intended to demonstrate alemtuzumab's superiority to one of the mainstays of first-line MS therapy.
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Labels: ECTRIMS CONGRESS 2013, Lemtrada, Rebif, Tysabri

Happiness and Multiple Sclerosis

Tandem bike a great equalizer for cyclists with different fitness levels

Phase IV Tysabri data #MS Research # MSBlog Effect of Tysabri

Mitoxantrone Study: Results from the 5-year, phase IV RENEW (Registry to Evaluate Novantrone Effects in WorseningMultiple Sclerosis) study.

Patient taking Novartis MS pill developed rare disease


Could Sleep Deprivation Aggravate Multiple Sclerosis?
 ABC News
Sleep Doubles Growth Of Brain Repair Cells. This explains why multiple sclerosis, an autoimmune disease that destroys myelin and kills oligodendrocytes, is so devastating. Hardened scars in the brain are the classic feature in the more than two million victims of the disease. Scientists at the University of Wisconsin-Madison (UoW) have discovered another reason why sleep is great! Resting boosts the growth of special cells — called oligodendrocytes — that repair the brain when it is injured, according to new findings reported in the Journal of Neuroscience.

High risk of cardiovascular diseases after diagnosis of multiple sclerosis
We recommend careful surveillance and preventive CVDs measures among MS patients, particularly among the women.

CAMPATH (Alemtuzumab) improves contrast sensitivity in patients with relapsing-remitting multiple sclerosis 
Alemtuzumab was associated with a greater chance of improved contrast sensitivity in patients with RRMS and may delay the worsening of visual function.


Migraine sufferers prone to poor blood flow

Migraines Linked to Structure of Brain Arteries

Longitudinal Change in Physical Activity & Its Correlates in Relapsing-Remitting Multiple Sclerosis

Retinal periphlebitis is associated with multiple sclerosis severity

Clinically silent PML and prolonged immune reconstitution inflammatory syndrome in a patient with multiple sclerosis treated with natalizumab (TYSABRI)

Protein kinase C polymorphisms and vitamin D levels in multiple sclerosis

Labor induction and augmentation in women with multiple sclerosis

CLICK ON "READ MORE" BELOW FOR 538 MORE STUDIES & ARTICLES WE   POSTED IN SEPTEMBER                                                                                                   

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Labels: Aubagio, Gilenya, Lemtrada, Novantrone, TECFIDERA, Tysabri

High dose thiamine improves fatigue in multiple sclerosis
The majority of the patients with multiple sclerosis (MS) experience  fatigue. Some observations indicate that fatigue and related manifestations concomitant with MS could be associated with an intracellular mild thiamine deficiency. Although blood thiamine and thiamine pyrophosphate levels were within normal limit in all the patients, high-dose thiamine therapy administered orally or parenterally led to an appreciable improvement of the fatigue.The administration of large quantities of thiamine was effective in reversing the fatigue in MS, suggesting that the abnormalities in thiamine-dependent processes could be overcome by diffusion-mediated transport at supranormal thiamine concentrations.


The Physiological Changes of MSMultiple sclerosis attacks the body’s central nervous system and can cause quite severe reactions and symptoms if not properly treated. Here are a few physiological changes of multiple sclerosis (MS) and the effect that they have on your body. Some of the most well-known symptoms of MS can include muscle weakness, vision trouble, coordination problems, memory issues and sensations of numbness. However, you might not realize just how this condition affects the body. It affects the brain and nervous system and each patient’s symptoms can be less or more severe than the next, depending on their individual condition.

A new study appearing in the latest issue of STEM CELLS Translational Medicine is the first to demonstrate that, in fact, adipose-derived stem cells donated by older people are less effective than cells from their younger counterparts.

Biogen Idec, Elan facing suits over Tysabri side effects-Allegedly failed to warn of risks
On Aug. 28 of last year Kimberley Yout, 45, was diagnosed with a rare brain infection that developed as a side effect of Tysabri, a drug she took for six years to keep her MS in check. Yout’s speech became slurred, her gait unsteady, and her future uncertain. Now, she is suing the two companies that marketed Tysabri — Biogen Idec Inc. of Weston and the Irish drug maker Elan Pharmaceuticals Inc.
The lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states. In each case, plaintiffs are seeking more than $1 million in punitive damages from Biogen Idec and Elan on behalf of patients or their families. After taking Tysabri, the patients developed progressive multifocal leukoencephalopathy, known as PML, an infection of the brain’s white matter that can cause death or severe disability. Her complaint, filed Friday, alleges they failed to adequately warn patients of the risks some face from prolonged use of Tysabri.more

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Labels: Lemtrada, SUNDAY RECAP, TECFIDERA, Tysabri