The FDA just announced yesterday the agency has approved the return of TYSABRI to the market with restrictive use!!!!
httBiogen Idec - TYSABRI® (natalizumab) Information Centerp://www.fda.gov/cder/drug/infopage/natalizumab/RiskMAP.pdf
For those of us with Multiple Sclerosis, this is "mega big-ass" good news! I, for one, have been anxiously awaiting the FDA decision since the other disease modifying drugs have not been too friendly to me.
My neurologist (Dr. She Who Will Not Be Named) assured me the drug would return to the market...she sat on the bigwig advisory board that made the recommendation to the FDA. But because I suffer from a lack of faith, I had resigned myself to the idea she might simply be trying to amuse me by blowing smoke up my arse (so to speak)!
For those of you who are interested, I embedded some links to the FDA press release and the requirements patients and doctors must meet before the drug can be distributed...there's quite a list.
For those of you who just want a "hit" on what this is, I'll simplify it for you here: Tysabri is a monoclonal antibody which had amazing results in slowing the progression of MS just prior to it being pulled from the market. It's an IV infusion given once a month (which beats the idea of daily, three times a week, or weekly self-administered shots...the current approved methods of treatment for MS). There was only one problem which resulted in its immediate withdrawal from the market last year...It may have killed a couple of people (but no one knows for sure) who developed PML or Progressive Multifocal Leukoencephalopathy, another deadly brain disease.
And as a reminder, there is no cure for MS, only drugs to help slow its progression. For those of us who had poor results from Copaxone or the Interferons, Tysabri represents a glimmer of hope. I'm not going to get all sentimental here and lapse into "hope" talk, however...just bring on the damn Tysabri and let's give it a whirl!!!
WOOHOO!
No comments:
Post a Comment