The U.S. Food and Drug Administration approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions).
Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. MS patients often experience muscle weakness and difficulty with coordination and balance.
“No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”
Tecfidera is made by Biogen Idec, Weston, Mass.
Tecfidera (dimethyl fumarate) formerly known as BG-12 is a newly approved oral therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS), the most common form of MS.
Tecfidera is the only known compound for the treatment of RRMS that has demonstrated activation of the Nrf-2 pathway.
The Nrf-2 pathway is a transcription factor or protein that is encoded by the NFE2L2 gene. The Nrf2 antioxidant response pathway is “the primary cellular defense against the effects of oxidative stress by increasing antioxidant enzymes.
Several drugs that stimulate the NFE2L2 pathway are being studied for treatment of diseases that are caused by oxidative stress, and Tecfidera (dimethyl fumarate) significantly reduced the progression of disability in multiple sclerosis.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit Biogenidec.com
I am very happy to see another oral disease modifying drug! Tell me if you feel the same in the comments below!