Category Archives: MS Treatment

Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment Update to label marks the conclusion of discussions initiated in December 2011 Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for Gilenya (fingolimod). The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The update marks the conclusion of discussions initiated in December 2011. The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observationperiod in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted. As of February 2012, approximately 36,000 … Continue reading →

Organizers of Marshall's eighth annual Multiple Sclerosis Walk meet at Mexico Lindo in preparation of the event Thursday, April 12. Pictured from left to right are: (front row) Lyle Pointer, Brenda Coffman and Leslie Coslet; and (back row) Donna Lovell, Mo Fowler, Jason Coffman, lead organizer Tracy Coffman and event chairman Brian Lovell. (Sarah Reed/Democrat-News) In Marshall, people are ready to support research and to find better treatments for Multiple Sclerosis. In its eighth year, organizers are hoping the MS Walk sees the same community support it has in the past. "I think everybody fights diseases in their own way, and this is the way we've all decided to help fight this ... to walk," said Donna Lovell. Started after organizer Tracy Coffman began walking for a cure in Sedalia, the Marshall MS Team was launched to support local residents with MS. Coffman was lucky in that she had symptoms of MS for less than a year before it was detected. Many go years without knowing. "There are so many different degrees," she said. "Things change from day to day." Approximately 400,000 Americans have been diagnosed with MS, according to the National Multiple Sclerosis Society. The central nervous system disease … Continue reading →

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that 12 data presentations, including six platform presentations, from the companys multiple sclerosis (MS) clinical trial programs for alemtuzumab and teriflunomide will be featured at the American Academy of Neurology's (AAN) 64th Annual Meeting in New Orleans, La., April 21-28. Presentations will include full data results from CARE-MS II (The Comparison of alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a Phase III trial investigating alemtuzumab in MS patients who had relapsed while receiving prior MS therapy, as well as new findings from the teriflunomide clinical program, one of the largest and broadest of any MS therapy in development. Genzymes robust development programs for alemtuzumab and teriflunomide were designed to understand how these therapies can best address significant unmet medical needs of people living with MS, said David Meeker, M.D., President and CEO, Genzyme. We are committed to becoming a long-term partner to the MS community with the goal of raising the expectation of what life with MS can be. Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by the U.S. Food & Drug Administration (FDA) and European Medicines Agency … Continue reading →

* EU review concludes Gilenya benefits outweigh its risks * EMA and FDA back stronger warnings for heart-risk patients * Novartis still sees drug as "blockbuster" (Adds U.S. label changes) LONDON, April 20 (Reuters) - European and U.S. regulators have backed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks. Novartis said the decision meant the drug remained on-track to be a "blockbuster" - one with annual sales above $1 billion. Prospects for Gilenya, the first multiple sclerosis (MS) pill of its kind, have been clouded by reports of its association with serious heart problems. The European Medicines Agency (EMA), which launched a review into the safety of Gilenya in January, said doctors should not prescribe it to patients with a history of cardiovascular and cerebrovascular disease or those on heart-rate lowering medication. If treatment with Gilenya was considered necessary in these patients, however, their heart activity should be monitored at least overnight following the first dose of the drug, it said. All patients getting the drug should have an electrocardiogram (ECG) and a blood pressure … Continue reading →

Early use of the multiple sclerosis drug interferon beta-1a might slow and even stop progression of the disease, according to new research from the American Academy of Neurology. Patients who received interferon soon after their first disease symptoms were less likely to see the disease progress into "clinically definite" multiple sclerosis, which is categorized as having had two separate attacks along with two separate lesions. Multiple sclerosis is an autoimmune disease that affects the brain and spinal cord. The disease attacks the myelin sheath, a protective covering that surrounds nerve cells. The disease is degenerative, and symptoms can vary. Patients suffer attacks that can last days, weeks or months. Symptoms affect the muscles, bowel function, vision, numbness, sexual function and personality. "While we've known it's beneficial to start MS drugs as soon as possible, this is the first trial to show a benefit of early injections of interferon beta-1a treatment at three years," Dr. Mark Freedman of the University of Ottawa in Ontario and a fellow of the American Academy of Neurology said in a statement. The three-year trial involved 517 people who had experienced their first MS symptoms, which includes tingling, numbness, muscle weakness or balance problems. The participants … Continue reading →

Canada's Health Minister Leona Aglukkaq announced Wednesday that the federal government will fund a clinical trial for "liberation treatment," an experimental vein therapy for multiple sclerosis developed by an Italian doctor. The MS Society of Canada, a co-funding partner of the project, said it's "thrilled" by the announcement that may bring "definitive answers" about the controversial treatment developed by Dr. Paolo Zamboni. The clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Canadians with multiple sclerosis seeks to determine the safety of venous angioplasty, also known as "liberation treatment" which requires the opening of blocked veins, the Canadian Institutes for Health Research said in a release about the announcement. Liberation treatment rejects long-held medical opinion that MS is an autoimmune disease. At least two Canadians have reportedly died overseas from complications of the procedure, which is currently unavailable in Canada. Asked about the controversy surrounding the procedure, MS Society of Canada CEO Yves Savoie said he supports the call of those concerned about the treatment for more rigorous research. "We're thrilled at this very important step and because of this question of the risk, that's why there are appropriate safeguards for participants going to be involved in that, including an … Continue reading →

Research and Markets (http://www.researchandmarkets.com/research/bfc499e5/analysis_of_the_eu) has announced the addition of Frost & Sullivan's new report "Analysis of the European Multiple Sclerosis Market" to their offering. European MS Market in Urgent Need of Novel Treatment and Diagnostic Options Limited awareness about the disease and its overall occurrence and progression among end-users is hampering the European multiple sclerosis (MS) market. This is being exacerbated by the limited availability of accurate diagnostic tools. There is, therefore, an immediate need for innovative and enhanced therapeutic and diagnostic tools that support improved diagnosis and expand the range of treatment options. The rising number of people suffering from MS is resulting in higher demand for related therapeutics, notes the analyst of this research. This, coupled with strong pipeline development, is pushing robust growth in the overall market. MS is characterised as a chronic disease, commonly diagnosed in patients between 20-50 years of age. It affects more than 2.5 million people across the world, with Europe accounting for nearly 550,000 cases. Significant research is currently underway to efficiently treat MS. Innovative treatment therapies, including biologics and oral drugs, are favouring market prospects. Refined drug delivery technologies, mode of drug delivery (oral or injectable), and several other factors will … Continue reading →

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the launch of a new interactive patient website called Ampyra Journeys (www.AmpyraJourneys.com). The site is the first-ever stand-alone patient site to focus on walking problems associated with multiple sclerosis (MS). Ampyra (dalfampridine) is an oral medication approved by the FDA as a treatment to improve walking in patients with multiple sclerosis. This was demonstrated by an increase in walking speed. The Ampyra Journeys website features true stories of people living with MS who have experienced walking problems and who took action to get treatment. Their stories explore the impact that walking problems can have for people living with MS, and how treatment that leads to improvements in walking can help people to regain the ability to perform many daily tasks. Prominent MS patient advocate, motivational speaker and entertainer Kristie Salerno Kent is among the patients who share their personal stories on http://www.AmpyraJourneys.com. I have met so many people living with MS who did not seek help when they started to experience walking problems. The important news is that treatment is available, and so I am very excited to be involved with Ampyra Journeys. This new website is a vital resource that can help … Continue reading →

Video footage from Patiala, Kapurthala prisons shows she is getting VIP treatment Hardly a few hours after her conviction and arrest on Friday evening, the former Punjab Cabinet Minister, Jagir Kaur, continued to wield political influence even as a prisoner of law. Video footage from the Patiala and Kapurthala jails clearly shows that Ms. Kaur who was convicted of criminal conspiracy and other charges in the case of the mysterious death of her 19-year-old daughter, Harpreet Kaur, in April 2000 and sent to jail was availing herself of VIP treatment. A CBI special court in Patiala had sentenced her to five years' rigorous imprisonment on counts of forcible abortion, wrongful confinement, abduction and criminal conspiracy. But she was absolved of the charge of murder. Three others were also convicted. Forced to quit as Minister for Rural Water Supply and Sanitation and Defence Services after her arrest, Ms. Kaur was accompanied out of the packed courtroom by police officials. It appeared that the police officials were escorting and guarding her from the crowd and media rather than taking her away as a convicted criminal, a lawyer in Patiala courts told IANS. She was led into a waiting air-conditioned grey colour Toyota … Continue reading →

COMPENSATION: Kate Campbell leaves court supported by her parents after being awarded almost $230,000 in injury compensation. Picture: Theo Fakos. Source: PerthNow ACCUSED: Luke Woollard leaves Perth District Court on the first day of a civil trial. Picture: Richard Polden Source: PerthNow A judge has ordered the son of a West Australian MP to pay nearly $230,000 to a woman who was seriously injured when he crashed his father's boat. Luke Woollard, 23, the son of Alfred Cove independent MP Janet Woollard, was sued in the District Court in Perth by Kate Campbell, 24, to recover more than $200,000 in medical bills, lost earnings and dental treatment. Ms Campbell was nearly killed when she slammed into the boat's dashboard and windscreen after a drunk Mr Woollard crashed into a navigation pylon near Perth's Canning Bridge in the early hours of November 7, 2007. Mr Woollard was ferrying people, including Ms Campbell, after a day and night of drinking to celebrate end-of-year university exams. In the District Court in Perth on Friday, Judge Philip McCann said he had found in favour of Ms Campbell and she should receive $229,627 in compensation. ``The trial was far harder than I ever expected it … Continue reading →