FDA approves Tecfidera/BG-12

[Just a small town girl]

I'll be curious to see what happens with the $10 co-pay program. Even with Novartis' co-pay assist. I was paying close to $800 a year for Gilenya.

Can't wait to switch!

[Grace]

Tecfidera

The website has been updated with the particulars of the medication, the prescription form and they announced a $10 copay program.

[South7]

Going to be asking my neuro about this at my next appt in May! Sooooo tired of the copaxone injections!
Yay!

[jessiesmom]

Full Tecfidera Prescribing Information

My dad is an M.D. who worked for the FDA for many years. He sent me a link with the full prescribing information for this drug. I have high hopes for it as I know many others do also.

http://www.tecfidera.com/pdfs/full-p...nformation.pdf

[Marco]

At biogen conference now. Party time has begun.

[jessiesmom]

Good news for all! BG-12 was approved by the FDA today. I understand that it will begin shipping next week. Here is the FDA announcement:

FDA NEWS RELEASE

For Immediate Release: March 27, 2013
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


FDA approves new multiple sclerosis treatment: Tecfidera

The U.S. Food and Drug Administration today 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. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. 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. Most people experience their first symptoms of MS between the ages of 20 and 40.

“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.”

Results from two clinical trials showed that those taking Tecfidera had fewer MS relapses compared to people taking an inactive pill (placebo). One of the trials showed that those taking Tecfidera experienced a worsening of disability less often than patients taking a placebo.

Tecfidera may decrease a person’s white blood cell count (lymphocytes). Lymphocytes help protect the body from infection and low counts can raise the risk of infection, although no significant increase in infections was seen in patients taking Tecfidera in clinical trials. Before starting treatment, and annually thereafter, the FDA recommends that the patient’s white blood cell count be assessed by their health care provider.

Flushing (warmth and redness) and stomach problems (nausea, vomiting, and diarrhea) were the most common adverse reactions reported by patients receiving Tecfidera in clinical trials, especially at the start of therapy. These side effects may decrease over time.

Tecfidera is made by Biogen Idec, Weston, Mass.