FDA approves new multiple sclerosis treatment Aubagio
Genzyme
(CBS News) The U.S. Food and Drug Administration (FDA) approved a new medication for the treatment relapsing forms of multiple sclerosis on Thursday.
Aubagio (teriflunomide) is a once-a-day tablet made by Genzyme, a subsidiary of Sanofi Aventis, that is intended for the treatment of adults with the disease.
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"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."
Multiple sclerosis - commonly known as MS - is a chronic, inflammatory autoimmune disease that attacks the central nervous system by blocking communication between the brain and body parts, the FDA said. The National Multiple Sclerosis Society estimates that 400,000 Americans have MS, with 200 new people diagnosed with the disease each week. Around the globe, 2.1 million people are living with the disease. Most people begin experiencing MS symptoms between the ages of 20 and 40, according to the National Institutes of Health.
The FDA added that MS is one of the most common cases of neurological disability in young adults and occurs twice as frequently in women compared to men. Most people with MS have times with worsening function known as relapses and then periods with no little or no symptoms called remission. Over time, however remission periods may shorten leading to continued decline in body functions and can cause complete or partial paralysis.
Recently, a study showed that the commonly prescribed injection, interferon beta, did not stop the progression of MS, but may benefit patients in other ways including reducing relapse. There is no cure for the disease currently.
People taking Aubagio may experience diarrhea, abnormal liver tests, nausea, and hair loss, and there is a boxed warning that describes an increased risk of liver problems, including death, and a risk of birth defects. Tests on animals have shown that it may cause fetal harm, so patients cannot be pregnant while on the tablet.The FDA recommends that doctors perform a blood test to check liver function before putting patient on the medication.
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Over the past year, CCSVI Clinic and its researchers and specialists have been studying the Combination venoplasty/autologous stem cell infusion protocol developed by Regenetek Cellular Technologies with the collaboration of outside labs and bioproducts manufacturers. As laboratory techniques gain ever-increasing sophistication based on new scientific methodologies for enhancing somatic cells into preferred lineages in vitro, the therapeutic outcomes for patients with neurological disorders have also been improving. Deb O'Connell who was treated at the Clinic in mid-September, 2012 recovered so quickly from her serious long-term degenerative disease condition that she experienced a wave of improvements while still in the hospital.
It's a matter of medical record that Deb had been wheelchair bound for 10 years (completely non-ambulatory) with multiple co-morbidities when she entered the program on September 9; she was 9.5 on the EDSS scale as assessed by a neurologist, was down to 80 lbs in body weight, could not breathe effectively, speak, or take in food by mouth due to dysphagia. Her pain was chronic and significant. When she left the Clinic on September 24th , she walked out of the doors and into a waiting van to go to the airport. At the time of her discharge from the Clinic, she could breathe normally, effectively speak once again, eat any types of food she desired and her pain had all but disappeared. At the time of this writing she is back home in Canada and reports that she continues to recover (especially her contractured hands), shows no signs of new disease symptoms, and has gained 18 lbs since her therapies, less than 3 weeks ago. She has now begun a regular physiotherapy program and is gaining walking strength and balance. The recapitulation of the course of her disease (MS) within days, provides evidence that the in vitro requirement of cell pluripotency has correctly been identified with respect to adult cell source origin, time, and manipulation in culture. For more information on the combination therapy protocol and study email to apply@ccsviclinic.ca or call 888-468-1554. http://www.ccsviclinic.ca/?p=1084
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