Category: Latest News

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.

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.

Please join MSAA for a new program focusing on helping parents and children build a better understanding of MS, develop peer connections, and strengthen the family.

During MS Awareness Month, the Multiple Sclerosis Association of America (MSAA) invites the MS community to participate in a wide array of activities and events to help manage their MS.

MS can impact not only physical and cognitive abilities, but also a person’s emotional wellbeing. In cooperation with the research organization Infogroup/ORC and supported by an unrestricted educational grant from Avanir Pharmaceuticals, the Multiple Sclerosis Association of America (MSAA) conducted an independent, online survey of almost 20,000 of its members in the fall of 2010. The purpose of this survey was to better understand the extent and impact of a particularly challenging neurological condition known to occur among people living with MS: pseudobulbar affect (PBA).

Triad Group, a Wisconsin-based manufacturing company, is voluntarily recalling all lots of their alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured under their name (Triad Group), or under third party names (Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, and Conzellin). These lots of alcohol prep products have been recalled as a result of potential contamination with Bacillus cereus — bacteria that could lead to life-threatening infections, particularly in those whose immune system is suppressed and for individuals undergoing surgery. As of January 5, 2011, Triad Group has received one report of a non-life-threatening skin infection.

Cladribine is an investigational oral drug being studied for the long-term treatment of relapsing forms of multiple sclerosis (MS). It was submitted to the United States Food and Drug Administration (FDA) for approval earlier this year, receiving Fast Track status in July 2010. Fast Track status reduces the FDA’s review time from 10 months down to six – and a decision was expected by November 28, 2010. However, the agency has extended the review time by three months, with a decision now anticipated by February 28, 2011.

On October 29, 2010, Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including multiple sclerosis (MS). PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.

Novartis Pharmaceuticals Corporation announced today that the United States Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). Gilenya is the first oral disease-modifying therapy available for the long-term treatment of MS. The approval of a treatment that may be taken orally (by mouth), versus injection or infusion, is exciting news for members of the MS community.

The oral medication FTY720 (fingolimod) has moved another step closer to approval as a new disease-modifying therapy for MS. The United States Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee reviewed the clinical trial data submitted by Novartis Pharmaceuticals Corporation (makers of FTY720), and reported its findings at a meeting held on June 10, 2010.