Tecfidera Approved for the Long-Term Treatment of MS
The United States Food and Drug Administration (FDA) announced that it has approved Tecfidera™ (dimethyl fumarate or DMF, formerly known as BG-12) for the treatment of relapsing forms of multiple sclerosis (MS). This is the 10th drug to be approved as a disease-modifying therapy (DMT) for the long-term treatment of multiple sclerosis (MS). Tecfidera is administered orally (by mouth) and is the third oral DMT approved for MS.
As with all of the approved DMTs for MS, Tecfidera is not a cure, but does slow MS disease activity. It reduces the number and severity of MS relapses (or symptom flare-ups) while reducing disease activity as seen on magnetic resonance imaging (MRI) scans — by reducing the number and size of brain lesions (areas of inflammation). Additionally, Tecfidera slowed the progression of sustained disability (in one of two large Phase III trials).
Please see MSAA’s online news article for more information!
http://www.drugs.com/news/ingredient-new-ms-linked-serious-brain-44267.html
In the April 25, 2013 issue of the New England Journal of Medicine (NEJM),1 two separate case studies are reported involving patients in Europe diagnosed with psoriasis who developed PML while taking different forms of dimethyl fumarate. The patient cases are described in Letters to the Editor with a response provided by Biogen Idec, maker of Fumaderm® (fumaric acid esters) tablets and Tecfidera™ (dimethyl fumarate) delayed release capsules.
PML is a serious brain infection caused by the reactivation of the JC Virus in patients who are immunosuppressed due to drug treatment or disease. Signs of PML include neurological symptoms which can be mistaken as MS symptoms. Risk factors for PML include presence of JC virus antibodies in the blood or cerebrospinal fluid and immunosuppression (often by use of certain medications).
In the April 25, 2013 issue of the New England Journal of Medicine (NEJM),1 two separate case studies are reported involving patients in Europe diagnosed with psoriasis who developed PML while taking different forms of dimethyl fumarate. The patient cases are described in Letters to the Editor with a response provided by Biogen Idec, maker of Fumaderm® (fumaric acid esters) tablets and Tecfidera™ (dimethyl fumarate) delayed release capsules.
PML is a serious brain infection caused by the reactivation of the JC Virus in patients who are immunosuppressed due to drug treatment or disease. Signs of PML include neurological symptoms which can be mistaken as MS symptoms. Risk factors for PML include presence of JC virus antibodies in the blood or
Thank you for your comment. MSAA does have a news update regarding this matter. You can read the article at the following link: https://www.mymsaa.org/news-msaa/858-pml-reported