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Australian Therapeutic Goods Administration (TGA) has cleared Genzyme's once daily oral Aubagio 14mg dose for the treatment of relapsing multiple sclerosis (MS).
Aubagio, which has anti-inflammatory properties, is expected to minimize activated lymphocyte count in the central nervous system.
Genzyme multiple sclerosis head Bill Sibold said with the TGA approval of Aubagio, healthcare professionals in Australia has a new once-daily option to treat people living with MS.
"The availability of AUBAGIO in the U.S. and subsequent registration in Australia not only demonstrates our continued progress, it also reflects our commitment to deliver differentiated treatments and provide access for patients globally," Sibold added.
The TEriflunomide Multiple Sclerosis Oral (TEMSO) trial data that revealed safety and efficacy profile of Aubagio was considered in the drug clearance.
MS Research Australia chairman professor Bill Carroll said, "It is important for people with MS and their clinicians to have access to a range of well-tolerated and convenient therapies that may reduce the impact of the disease on their lives and suit their lifestyle."
The immunomodulator earlier received approval in the US, while marketing applications submitted to the European Medicines Agency and other regulatory bodies are still under review.
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, BSN, RN, Nurse Planner
Time to secondary progression in multiple sclerosis (MS), not the frequency of early inflammatory attacks, was the strongest predictor of severe disability later on, researchers found.
The likelihood of needing a cane for walking was reduced by 24% among patients who were free from progression for 5 years (OR 0.76, 95% CI 0.69 to 0.84), according to George C. Ebers, MD, of the University of Oxford in England, and colleagues.
In addition, the probability of needing a walking aid fell by 42% (OR 0.58, 95% CI 0.51 to 0.67) for those without progression for 10 years and by 56% (OR 0.44, 95% CI 0.37 to 0.52) for those remaining progression-free for 15 years, the researchers reported online in Archives of Neurology.
"This study provides evidence that severe disability accumulation is induced by mechanisms tied to the onset and evolution of the progressive phase, which are largely independent of inflammatory attacks," they observed.
Despite previous experience showing that the number of early relapses in MS correlates poorly with eventual disability, the rate of these attacks is often used as a marker for progression to disability, particularly in clinical trials.
A new study has identified and “immune exchange” that allows disease-causing cells in patients with multiple sclerosis to move in and out of the brain. Researchers state that this exchange may be the key to better treatments and diagnostics in the future.
According to the study’s authors, one current theory on multiple sclerosis holds that self-reactive B cells in the brain activate and cause inflammation. The exchange of B cells uncovered by the new study could mean that the B cells are “accessible” when moving from the brain.
“The hope is that if we can identify culprit B cells, using precise tools, we will be able to better diagnose multiple sclerosis and monitor disease activity,” said Dr. Hans Christian von Büdingen, lead author of the study and neurologist at the University of California at San Francisco (UCSF). “In addition, in ways that may have to be tailored for each patient, this may also allow us to develop therapies that directly target disease-causing B cells.”
Each day, it becomes
tougher for Howard Chiet to get around his Wellington home. "I
progressed from a cane to a walker, from a walker to a wheelchair," he
On November 13, 1989, Chiet was diagnosed with multiple sclerosis.
Chiet gave up driving a car twelve years ago. He spends his days now in a
"Happy where I am,
if they can stop where I am right now," he said. But stopping the
progression of his particular case of M.S. is not an option, even as medical
researchers with Northwestern University say they have made a breakthrough
using something called nanotechnology to slow or even stop the progression of
some forms of M.S. in mice.
November 18, 2012 In a breakthrough for nanotechnology and multiple sclerosis, a biodegradable nanoparticle turns out to be the perfect vehicle to stealthily deliver an antigen that tricks the immune system into stopping its attack on myelin and halt a model of relapsing remitting multiple sclerosis (MS) in mice, according to new Northwestern Medicine research The new nanotechnology also can be applied to a variety of immune-mediated diseases including Type 1 diabetes, food allergies and airway allergies such as asthma. In MS, the immune system attacks the myelin membrane that insulates nerves cells in the brain, spinal cord and optic nerve. When the insulation is destroyed, electrical signals can't be effectively conducted, resulting in symptoms that range from mild limb numbness to paralysis or blindness. About 80 percent of MS patients are diagnosed with the relapsing remitting form of the disease. The Northwestern nanotechnology does not suppress the entire immune system as do current therapies for MS, which make patients more susceptible to everyday infections and higher rates of cancer. Rather, when the nanoparticles are attached to myelin antigens and injected into the mice, the immune system is reset to normal. The immune system stops recognizing myelin as an alien invader and halts its attack on it. "This is a highly significant breakthrough in translational immunotherapy," said Stephen Miller, a corresponding author of the study and the Judy Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine. "The beauty of this new technology is it can be used in many immune-related diseases. We simply change the antigen that's delivered." "The holy grail is to develop a therapy that is specific to the pathological immune response, in this case the body attacking myelin," Miller added. "Our approach resets the immune system so it no longer attacks myelin but leaves the function of the normal immune system intact."