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Thursday
RRMS Drug Works by Shifting Anti-Inflammatory Immune Profile, Study Shows Lemtrada (Alemtuzumab) treatment seen to raise levels of regulatory T-cells and anti-inflammatory cytokines
Alemtuzumab treatment seen to raise levels of regulatory T-cells and anti-inflammatory cytokines
Researchers have found that changes in the composition of immune molecules — specifically, a shift to more anti-inflammatory cytokines and regulatory T-cells (Tregs) — likely account for the efficiency of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (RRMS).
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Wednesday
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, Gilenya, Lemtrada, Rituxan-Rituximab, TECFIDERA, Tysabri
Thursday
First MS patients treated with Genzyme’s Lemtrada in US
Genzyme has announced that the first patient with relapsing forms of multiple sclerosis (MS) has been treated with Lemtrada (alemtuzumab).
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Labels: Lemtrada
Sunday
BUDDY ALLEN WANTS & NEEDS LEMTRADA
When Robert “Buddy” Allen could no longer run after a Frisbee, he thought the cause was an old childhood injury -- when he got hit by a car. A neurologist, a chiropractor and an orthopedic surgeon all weighed in on Allen’s symptoms, which included tightness in his right leg and an overall stiffness in his body, but no one could pinpoint the culprit.
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Labels: Lemtrada
Patients, investors react to Genzyme's second attempt for approval of multiple sclerosis drug Lemtrada
GENZYME TO RESUBMIT APPLICATION TO FDA FOR NEW MS DRUG LEMTRADA
FDA panel supports approval of Sanofi's MS drug Lemtrada
Genzyme’s Lemtrada™ Approved In Canada For Treatment Of Multiple Sclerosis
LEMTRADA FDA REJECTION NEWS: Genzyme Receives Complete Response Letter From FDA On Lemtrada™ (alemtuzumab) Application
MS community shocked by FDA's rejection of drug Lemtrada
Harold Johnson was going downhill fast. The medication he injected three times a week for his multiple sclerosis was making him feel like a zombie, and it wasn’t helping. His vision was getting worse, and he would choke when eating or drinking, and would
“The day that bothered me the most was when I went to my mom and dad’s house on Mother’s Day. I had to use a cane to walk in front of my mom,” said Johnson, 43, of Swansea. “That affected me.” Things dramatically changed about four years ago, after Johnson began taking part in a study of the experimental drug Lemtrada.The canes and walker he sometimes used are collecting dust in his hallway. He can ride his bike, play in the park with his dog, build robots in his basement and work full time as a computer technician at Southwestern Illinois College. Imaging of his brain shows no new damage. “Within three weeks, I felt like Superman,” Johnson said. He even got married.
Read more » |
| Harold Johnson, 43, shows off his agility and balance during his daily walk in the Melvin Price Memorial Park near his home in Swansea on Sunday, Feb. 16, 2014, while still holding on to his dog, |
Labels: Lemtrada
Merck KGaA shores up Rebif defenses to fend off new MS rivals
Merck KGaA shores up Rebif defenses to fend off new MS rivals
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, Extavia, Gilenya, Lemtrada, Rituxan-Rituximab, TECFIDERA, Tysabri
Friday
Sanofi MS Drug Added With Genzyme Fails to Win FDA Approval
Sanofi (SAN) failed to win U.S. regulatory approval for its multiple sclerosis drug Lemtrada, denting the company’s ambitions of capturing a larger share of the $20 billion market for the disease.
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 AGâs (NOVN) Gilenya and Merck KGaA’s Rebif.
Read more »
Labels: Avonex, Copaxone, Gilenya, Lemtrada, TECFIDERA, Tysabri
Thursday
BioTrends Research Group Rolls Out The TreatmentTrends: Multiple Sclerosis 2013 Report
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, Copaxone, Gilenya, Lemtrada, TECFIDERA, Tysabri
Wednesday
Surveyed Neurologists Report Significantly Higher Relapsing-Remitting Multiple Sclerosis Patient Shares for Gilenya and Tysabri, Compared With One Year Ago
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."
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Labels: Aubagio, Avonex, Copaxone, Gilenya, Lemtrada, TECFIDERA, Tysabri
Monday
CORRECTED-FDA panel says safety issues do not rule out Sanofi MS drug approval
Low-Contrast Visual Tests Reveal Better Alemtuzumab Efficacy
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Labels: Lemtrada
ECTRIMS Congress 2013: A low-dose regimen of the leukemia drug alemtuzumab (Lemtrada) slashed annualized relapse rates
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| 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 |
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: Copaxone, ECTRIMS CONGRESS 2013, Lemtrada, Tysabri
Sunday
A NEW CLASS OF MS DRUGS COMING SOON: protein based therapies (monoclonal antibodies) that are more target specific & cause less damage to the body. Genzyme’s Lemtrada will be among the first of these drugs to hit the market, with a recent approval in Europe
Currently existing immunomodulatory drugs that treat Multiple Sclerosis only work to treat relapse or attacks, manage symptoms, or modify the course of the disease. These drugs have too many side effects due to their lack of target specificity. Another class of drugs, recently being developed, are protein based therapies (monoclonal antibodies or mAbs) that are more target specific and cause less damage to the body.Read more »
Labels: Aubagio, Avonex, Betaseron, Lemtrada, TECFIDERA, Tysabri