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News from MSAA

Highlights from the American Academy of Neurology's Annual Meeting

May 8, 2013

The American Academy of Neurology's (AAN) 65th Annual Meeting took place in San Diego, California in March. This large medical conference presents the latest findings in research and treatments for neurological conditions, including multiple sclerosis (MS). To follow are some important highlights.
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PML Reported in Psoriasis Patients Taking Fumaric Acid Medications in Europe

April 26, 2013

Two cases of progressive multifocal leukoencephalopathy (PML) in individuals taking either fumaric acid or a compound of fumaric acid esters were reported in The New England Journal of Medicine (N Engl J Med 2013;368;17:1657-1660) on April 25, 2013. PML is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. Both of these reports were from Europe in individuals receiving long-term treatment for psoriasis (a chronic skin problem that causes skin cells to grow too quickly, resulting in thick, white, silvery, or red patches of skin [WebMD]).
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Tecfidera Approved for the Long-Term Treatment of MS

March 28, 2013

The United States Food and Drug Administration (FDA) announced on March 27, 2013 that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) as a first-line therapy for the long-term treatment of relapsing forms of multiple sclerosis (MS). Tecfidera’s parent company, Biogen Idec, submitted a New Drug Application (NDA) to the FDA for the approval of this drug in February 2012. (Read the FDA’s press release on the approval of Tecfidera.)
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March is Multiple Sclerosis Awareness Month

March 1, 2013

The Multiple Sclerosis Association of America (MSAA) recognizes March as MS Awareness Month. Throughout March, MSAA encourages individuals to expand their knowledge, understanding, and support of individuals whose lives are affected by multiple sclerosis (MS).
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The Multiple Sclerosis Association of America Launches New Website

February 21, 2013

The Multiple Sclerosis Association of America (MSAA) is pleased to introduce its new website, mymsaa.org.
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Multiple Sclerosis Association of America Teams Up With SwimOutlet.com To Promote Swim For MS

February 13, 2013

The Multiple Sclerosis Association of America (MSAA) is pleased to announce its new partnership with SwimOutlet.com to help promote the charity’s national fundraiser, Swim for MS. Serving as the distribution sponsor for Swim for MS, SwimOutlet.com will feature promotional information and ongoing updates on swim events through newsletter articles, targeted email campaigns, and posts on social media including Facebook and Twitter. 
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Flu and Flu Vaccine Information

January 10, 2013

Recent news reports and statistical information indicate that this year the incidence rate for seasonal influenza (flu) is already high and is widely impacting communities across the nation. The good news is that the flu immunization prepared for the 2012-2013 flu season appears to be very well matched to those flu strains occurring across the country; therefore, preventative measures such as obtaining a flu vaccine may be helpful in preventing the contraction of the flu.
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MSAA's Mobile Phone App Launches in the Android Marketplace

November 15, 2012

My MS Manager™, the Multiple Sclerosis Association of America’s Mobile Phone App for the MS Community, Launches in the Android Marketplace

Cherry Hill, New JerseyMy MS Manager™, the first-of-its-kind mobile phone application developed to help individuals better manage their MS, is now available on the Android platform. Since its launch in the Apple App Store in June of 2011, My MS Manager has been downloaded more than 9,000 times, with users entering data about their MS on various Apple mobile products.
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Emergency and Assistive Services in Response to Hurricane Sandy

November 2, 2012

The impact of Hurricane Sandy to the residents of the mid-Atlantic, Northeastern, and Midwestern United States has been devastating. MSAA’s staff is deeply saddened by the tragic loss of life as well as the destruction of personal possessions, homes, and businesses, caused by this storm.
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Aubagio® (Oral Teriflunomide) Receives FDA Approval

September 13, 2012 - Updated: September 17, 2012

On September 12, 2012, Sanofi and its subsidiary Genzyme announced that the United States Food and Drug Administration (FDA) had approved their new drug, Aubagio® (oral teriflunomide), for relapsing forms of multiple sclerosis (MS). The FDA had accepted their New Drug Application (NDA) in October, 2011. This is the ninth disease-modifying therapy approved by the FDA for the long-term treatment of MS. Of these nine, Aubagio is the second approved medication for MS that is taken orally.
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MSAA Receives APEX Award for Publication Excellence

Multiple Sclerosis Association of America's Webinar "How to S.E.A.R.C.H.™ for the Right MS Therapy for You!" Wins Award

August 10, 2012

MSAA is proud to announce that a 2012 APEX Award for Publication Excellence has been given to our online video webinar, "How to S.E.A.R.C.H..™ for the Right MS Therapy for You!" This is the first APEX Award MSAA has received in the category of webinars and the eighth APEX Award received overall. This year's APEX award competition drew approximately 3,400 entries across a range of 11 categories.
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Highlights from The Consortium of Multiple Sclerosis Centers Annual Meeting, Held in San Diego (May 31 - June 4, 2012)

July 24, 2012

Editor's note: For easier reading, certain definitions have been included within the text and are often repeated throughout the article. Additionally, for easier reading, a brand name of an approved drug is used versus the generic name wherever possible.

The Consortium of Multiple Sclerosis Centers (CMSC) annual meeting provides a unique opportunity for MS professionals to come together in an interdisciplinary setting to discuss all aspects of MS care. Attendees include physicians, nurses, physical and occupational therapists, psychologists, social workers, and other MS professionals. Topics are wide-ranging, from the latest advances in research and symptom management, to practical workshops designed to improve hands-on care.
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Supreme Court Upholds Affordable Care Act

June 28, 2012

On June 28, 2012 a historic decision was made by the United States Supreme Court to uphold the Affordable Care Act (ACA). The ACA was originally approved by Congress and was then signed into law on March 23, 2010. The law was designed to make many changes to the way the healthcare and insurance systems work in the United States, with most of the scheduled changes requested to be implemented within a four-year period, or by the end of 2014.
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Multiple Sclerosis Association of America's MRI Institute Marks 10 Years of Helping Individuals with Multiple Sclerosis Obtain MRIs

June 26, 2012

Multiple Sclerosis Association of America's MRI Institute Marks 10 Years of Helping Individuals with Multiple Sclerosis Obtain MRIs

The Multiple Sclerosis Association of America (MSAA) is proud to mark the 10-year anniversary of one of its most sought after programs - the MRI Institute. This program is designed to help people who have been diagnosed with multiple sclerosis (MS) and lack health insurance coverage, acquire an MRI scan. The Institute has been supported by the pharmaceutical companies EMD Serono, Inc. and Pfizer Inc since 2002. During that time, the Institute has helped over 7,500 individuals who have MS and could not otherwise afford an MRI to monitor their multiple sclerosis.
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Highlights from The American Academy of Neurology's Annual Meeting

Highlights from The American Academy of Neurology's Annual Meeting, Held in New Orleans (April 21-28, 2012)

June 22, 2012

Editor's note: For easier reading, certain definitions have been included within the text and are often repeated throughout the article. Additionally, for easier reading, a brand name of an approved drug is used versus the generic name wherever possible.

Introduction

This year's American Academy of Neurology (AAN) meeting was especially exciting for multiple sclerosis (MS) clinicians and researchers. Results were presented from clinical trials that have been ongoing for the past three-to-four years, many of which focus on the "new generation" of oral drugs for managing MS progression. Studies have looked at the effectiveness and safety of the new agents, particularly as compared to the standard injectible drugs that became available starting in the early 1990's. Data on these new agents have been released gradually as the studies progressed through the clinical trials process, and anticipation of the details from completed studies has been building.
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Dive into Action Today with MSAA's Swim for MS Pool Party!

Multiple Sclerosis Association of America Offers a Unique Volunteer Opportunity for Individuals Interested in Making a Difference This Summer for the Multiple Sclerosis Community

June 20, 2012

The Multiple Sclerosis Association of America (MSAA) is proud to offer volunteers the opportunity to dive into action through the Swim for MS Pool Party. An offshoot of MSAA's popular Swim for MS program, the Pool Party is a one-day event volunteers host in their own backyard or community pool. To begin to plan their Swim for MS Pool Party, volunteers first select a date, then select an activity - such as cannonballs, swimming laps or even a game of Marco Polo - and finally collect pledges from friends and family for the activity chosen. It's as easy as 1-2-3!
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FDA Issues CCSVI Treatment Warning

May 14, 2012

On May 10, 2012, the United States Food and Drug Administration (FDA) issued a warning about experimental therapies aimed at treating chronic cerebrospinal venous insufficiency (CCSVI). This is a complex condition involving changes in blood flow from the brain back to the heart, caused by the twisting or collapse of certain veins located on the outside of the brain.
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New Prescribing Information for Gilenya

April 25, 2012

On April 20, 2012, Novartis announced changes to the prescribing information for Gilenya® (fingolimod) in the treatment of relapsing forms of multiple sclerosis (MS). This new prescribing information is applicable only to individuals who have not been given a first dose of Gilenya or for those who have stopped and will be restarting the drug. These changes do not affect any guidelines for individuals who are currently taking Gilenya.
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Awaiting FDA Review: MS Patient with PML on Gilenya after Tysabri

April 17, 2012

Novartis released a safety information update on April 13, 2012 stating that an individual with MS who was taking Gilenya® (fingolimod) was diagnosed with progressive multifocal leukoencephalopathy (PML). This infection of the brain has been associated with another treatment for MS, Tysabri® (natalizumab). Depending on the risk factors discussed below, a small number of MS patients may develop PML either while taking Tysabri or up to three months after discontinuing this drug.
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FDA Approves Avonex® Pen™ and Initial Dosing Regimen

March 7, 2012

Biogen Idec announced last week that the United States Food and Drug Administration (FDA) has approved both a new device (the Avonex Pen) as well as a new dosing regimen for Avonex (interferon beta-1a). These two approvals are aimed at assisting patients who are either taking Avonex presently, or who are just starting Avonex, for the treatment of relapsing forms of multiple sclerosis (MS).
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Biogen Idec Submits Application for BG-12

March 7, 2012

Biogen Idec announced last week that they have submitted an application to the United States Food and Drug Administration (FDA) for approval of BG-12 (dimethyl fumarate), an experimental oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS). The company plans to also submit an application for the same drug to the European Medicines Agency (EMA) shortly. Biogen Idec expects to hear back from these two agencies within a few months regarding the status and potential approval of BG-12.
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March is Multiple Sclerosis Awareness Month

March 1, 2012

The Multiple Sclerosis Association of America (MSAA) is pleased to recognize March as MS Awareness Month. During the month of March, MSAA will be highlighting various programs designed to expand knowledge, understanding, and support of individuals whose lives are affected by multiple sclerosis (MS).
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Antibody Test Identifies New Risk Factor for PML

January 27, 2012

On January 20, 2012, the United States Food and Drug Administration (FDA) announced that three factors are now identified with increasing the risk of Progressive Multifocal Leukoencephalopathy (PML) for individuals with multiple sclerosis (MS) being treated with Tysabri® (natalizumab). PML is a potentially fatal brain infection with the JC virus (JCV), in people with weakened immune systems. The FDA has approved a labeling change, which adds the results of a newly approved test for the presence of anti-JCV antibodies, to the two previously listed risk factors.
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MSAA Honored in the first Web Health Awards | MOBILE for My MS Manager™

January 27, 2012

The Multiple Sclerosis Association of America (MSAA) is pleased to announce My MS Manager ™, MSAA's mobile phone application, has been honored by the Web Health Awards | MOBILE with a Merit Award in the category of Mobile Application: Chronic Disease Management; Small Mobile Device in the Association/Professional Society/Non-Profit division.
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European Agency Recommends Increased Monitoring with First Dose of Gilenya

January 20, 2012

The European Medicines Agency (EMA) announced today that it has started a review of Gilenya (fingolimod) in response to reports of potential heart issues associated with the first dose of this drug.
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Potential Drug-Packaging Problem

January 11, 2012

The United States Food and Drug Administration (FDA) has notified the public that a packaging problem may have occurred with eight narcotic-type drugs (such as Opana®, Percocet®, and Endocet®), where a stray pill may have gone into another's packaging.
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Gilenya News Update

December 13, 2011

On December 20, 2011, the FDA posted a Safety Announcement on its website, noting the death of an individual with MS on the day following a first dose of Gilenya. The article states: "At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation." It also advises: "Patients with MS should not stop taking Gilenya without talking to their healthcare professional."

View the entire FDA Safety Announcement

Novartis Pharmaceuticals Corporation has informed the Multiple Sclerosis Association of America (MSAA) that a patient with multiple sclerosis (MS), who had been given one dose of Gilenya® (fingolimod), died on the following day. The individual's death occurred on November 23, 2011.
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FDA Launches Website on Safe Disposal of Used Needles

November 10, 2011

The United States Food and Drug Administration (FDA) recently announced that they have launched a new website (www.fda.gov/safesharpsdisposal) devoted to information and instruction for the safe disposal of needles and other "sharps" used by individuals at home, work, and while traveling. In addition to standard needles and syringes, other dangerous medical supplies for disposal include items such as lancets or finger-stick devices for blood testing; needle and tubing systems, plus connection needles for hemodialysis at home.
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CCSVI Update

November 10, 2011

Background Information on CCSVI and MS

Many questions still surround the possible connection between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis (MS). CCSVI is a complex condition involving changes in blood flow from the brain back to the heart, which some researchers theorize could possibly lead to activation of the immune system, excess iron deposits, loss of myelin, and other nervous system damage.
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ECTRIMS Update 2011

Highlights from the ECTRIMS/ACTRIMS Joint Meeting - Amsterdam, October 19-22, 2011

October 19-22, 2011

This year's joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS) was extremely well attended. More than 7,000 professionals attended the meeting, which featured more than 1,000 presentations - all in a whirlwind three-and-a-half days.

The following highlights review only a few of the many topics discussed at the meeting, but they reflect research of ongoing interest to the entire MS community.
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Multiple Sclerosis Association of America Honored for Publication Excellence

September 15, 2011

The Multiple Sclerosis Association of America (MSAA) is pleased to announce awards for two of its publications.
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Multiple Sclerosis Association of America and National Disability Institute Launch a Four-Part Webinar Series on Financial Wellness for the Multiple Sclerosis Community

September 14, 2011

The Multiple Sclerosis Association of America (MSAA) and National Disability Institute (NDI) are collaborating on a series of four free webinars designed to assist the MS community in learning about strategies to protect and improve their financial well-being.
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Botox® Approved for Urinary Incontinence

August 26, 2011

On August 24, 2011, Allergan, Inc. announced that the United States Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA) injection for the treatment of urinary incontinence. Specifically, the approval is for adults who experience "detrusor over-activity" resulting from a neurological condition, such as multiple sclerosis (MS) and who either do not respond adequately or are intolerant of anticholinergic medications.
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Article Published on the Cost Effectiveness for Treating MS

August 3, 2011

Overview: Much attention has been focused on an article appearing in the July 26 issue of Neurology (vol. 77, pages 355-363) titled, "Cost-effectiveness of disease-modifying therapies for multiple sclerosis." This article presents the results of a study that looks at several factors in an effort to estimate the overall 10-year expense versus benefit associated with the long-term treatments for MS, in combination with other costs and lost wages.
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Identifying and Meeting the Needs Associated with Primary-Progressive MS

July 15, 2011

An informative article on primary-progressive multiple sclerosis (PPMS) appears in the summer 2011 issue of the International Journal of MS Care. "Meeting the Needs of People with Primary Progressive Multiple Sclerosis, Their Families, and the Health-Care Community" is part of a collaborative project between the Multiple Sclerosis Association of America (MSAA) and the National Multiple Sclerosis Society (NMSS) to recognize the needs of this specific population and to create programs to help answer these needs.
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Merck Serono No Longer Seeking Approval for Oral Cladribine

June 23, 2011

Cladribine Tablets were expected to be one of the next approved disease-modifying therapies to treat relapsing forms of multiple sclerosis (MS). Merck Serono announced on June 22, 2011 that they will no longer seek global approval for the drug.
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Multiple Sclerosis Association of America Launches Mobile Phone App for the Multiple Sclerosis Community

June 15, 2011

My MS Manager is the Multiple Sclerosis Association of America's new mobile phone application, provided free of charge to individuals with multiple sclerosis (MS) or their care partner to use on their iPhone, iPad or iPod touch. Developed in conjunction with Ringful Health, My MS Manager is available now for download in the Apple iTunes Store.
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Multiple Sclerosis Emerging Therapies Collaborative

March 23, 2011

We are proud to announce the launch of the Multiple Sclerosis Emerging Therapies Collaborative. The Collaborative - which includes the members of the MS Coalition, the American Academy of Neurology, and the VA Multiple Sclerosis Centers of Excellence East and West - has as its mission: To develop and disseminate timely, evidence-based resources to persons affected by multiple sclerosis and health care professionals, in order to  promote optimal, individualized treatment of the disease by facilitating effective communication and medical decision-making.
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Oral Cladribine Denied FDA Approval

March 2, 2011

EMD Serono, Inc., makers of Cladribine Tablets (an oral formulation of cladribine), announced today that they received a complete response letter (CRL) from the United States Food and Drug Administration (FDA). The FDA issues a CRL when it has completed the review of an application. However, in this situation, the FDA was not able to approve the application without additional information. The announcement was disappointing to members of the MS community, who were hoping to see another option added to the list of available disease-modifying therapies for the long-term treatment of MS.
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